Please note that this position can be based in San Diego, CA OR Princeton, NJ OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations. 

Primary Responsibilities

• Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
• Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
• Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
• Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
• Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
• Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
• Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
• Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
• Other duties as assigned

Education and Experience

• Bachelor’s degree in a Life Sciences or related field.  An equivalent combination of education and applicable job experience may be considered.
• Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
• American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.

Key Skills:

• In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
• Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
• Strong ability to interpret and apply U.S. and international cGMP requirements
• Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
• Ability to translate quality standards into practical implementation and review activities
• Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
• Strong collaboration skills with the ability to influence and gain cooperation across functions
• Willingness to travel domestically and internationally (approximately 25–30%)

Scope

Manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems.  Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

ESSENTIAL JOB FUNCTIONS:

• Manage Senior Accountant and ensure timely, accurate processing of journal entries, reconciliations and various account analyses for R&D functions such as translational research, development, diagnostics, pharmacology, and regulatory affairs, and adherence to company policies.
• Review and approve invoices for payment. Ensure proper coding, two-way match, and approval workflows.
• Perform and review journal entries and balance sheet reconciliations for key accounts such as accrued R&D contracts, prepaid R&D ST, and prepaid R&D LT.
• Review various related parties and partner transactions including reconciliations, and analysis.
• Perform and review monthly and quarterly variance analyses for operating expenses, R&D functions, projects, and key accounts; investigate and resolve discrepancies proactively.
• Ensure compliance with U.S. GAAP, SOX requirements, and internal accounting policies across all responsible functions and processes.
• Support the design, implementation, and ongoing maintenance of Sarbanes‑Oxley internal controls, including documentation and testing.
• Assist with external financial audits by preparing schedules and responding to auditor requests and inquiries.
• Review monthly purchase order coding, partner with project managers and accounting staff to ensure proper coding for all new purchase orders.
• Apply strong analytical skills and critical thinking to identify issues, recommend improvements, and enhance the accuracy, efficiency, and quality of accounting processes.
• Perform additional duties and ad hoc projects as needed to support Finance leadership and departmental goals

Job Specifications:

• Bachelor’s degree in accounting, or other related discipline, or the equivalent knowledge and experience required.
• Experience in the biotech/pharmaceutical industry required
• A minimum of 6-8 years’ relevant accounting experience, preferably in a combination of the following monthly close process, bank reconciliations, balance sheet reconciliations, contract accruals
• Excellent communication and people skills and the ability to interface with various levels of co-workers, upper management, and external customers while maintaining a high degree of confidentiality.
• Experience working in publicly traded company and life science industry preferred.
• Knowledge of US GAAP and internal control principles for a public corporation.
• ERP experience required; experience with NetSuite, Blackline, Coupa and Concur preferred.
• Skilled in the use of Microsoft Office Suite with intermediate to advanced Excel skills.
• Detail oriented with good analytical skills.
• Exercises independent judgment in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross-functional decisions.
• Serves as a key point of contact for cross-functional partners withing their area, ensuring alignment and proactively addressing coordination needs to support team deliverables.
• Strong time management skills and ability to independently organize multiple tasks of varying priorities and meet critical deadlines in a fast-paced environment.
• Ability to work in team environment and willing to assist other team members to achieve team goals and objectives.

The base range for this role at a Senior Manager level is $143,000 - $176,500. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in supporting the ongoing maturation of our Quality Management System (QMS) and providing QE expertise on Element’s on-market products. This role is ideal for someone who is passionate about continuous improvement and cross-functional collaboration to achieve greater outcomes. We are looking for candidates with a solid QE background in medical devices (Class I-II). Experience with developing strong working relationships with teams to maintain our quality culture is a must. This role will report to the Senior Manager, Quality Engineering and will be a San Diego based role.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Essential Functions and Responsibilities:

• Collaborate with cross-functional teams to gather feedback and lead / support continuous improvement of QMS processes, including but not limited to supplier controls, equipment onboarding/qualification, process / design verification and validation, CSV, etc.
• Lead / support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation
• Interpret regulations and requirements to support efforts related to Risk Management (FMEA), Design History File (DHF), Design Master Records (DMR), Device History Records (DHR).
• Provide quality engineering expertise throughout all product lifecycles, from design and development to post-market surveillance, requiring solid understanding of the company’s product portfolio and close collaboration with multiple functions (R&D, Engineering, Mfg, Supply Chain, Commercial, Software etc.)

Education and Experience:

• Bachelors degree in Engineering or related technical discipline (an equivalent combination of experience and education may be considered)
• A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry
• Experience with ISO13485 and ISO 14791 is required. Experience with IEC 62304 is strongly preferred.
• Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
• Strong collaboration skills and ability to drive decisions across multidisciplinary teams
• Self-motivated and able to organize and prioritize multiple tasks
• Strong analytical skills, reporting, and data analysis are strongly preferred
• Experience working with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
• ISO13485 Lead Auditor certification and ASQ CQE certification is a plus

Physical Requirements:

• Frequently moves boxes weighing up to 20 pounds

Location:

• San Diego (onsite)

Travel: 

• Domestic travel up to 10%

Job Type:

• Full-time/Exempt

Base Compensation Pay Range:

• $97,000 - $118,000

In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off. 

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Want to help us help others? We’re hiring! 

GoFundMe is the world’s most powerful community for good, dedicated to helping people help each other. By uniting individuals and nonprofits in one place, GoFundMe makes it easy and safe for people to ask for help and support causes—for themselves and each other. Together, our community has raised more than $40 billion since 2010.

Join us! The GoFundMe Pro team is searching for our next Outbound Development Representative!

Are you a dynamic, high-performing, and hyper-organized professional ready to advance your sales career? GoFundMe Pro’s sales team is hiring a Outbound Development Representative (BDRs/EDRs) to connect nonprofits with innovative fundraising technology that helps amplify their mission and raise more funds online. The ideal candidate has previous sales development experience, thrives in a fast-paced environment, and knows what it takes to be a top performer.

As an Outbound Development Representative, you will play a critical role as the first point of contact for prospective GoFundMe Pro customers. You’ll embrace emerging technology to execute high-volume, strategic, and personalized outreach that resonates with nonprofit decision-makers. Your responsibilities include uncovering fundraising challenges, building tailored engagement plans, and fostering meaningful relationships across departments. You'll facilitate qualifying calls, conduct discovery sessions with key stakeholders, and showcase the value of GoFundMe Pro’s tools, all while managing a high-quality sales pipeline to ensure a seamless handoff of qualified prospects to our Account Executive team.

This role provides a unique opportunity to support multiple Account Executives in either the Commercial or Enterprise sector, giving you valuable insight into advanced sales strategies and mentorship to grow your business acumen. At GoFundMe Pro, you’ll thrive in an environment where innovation, collaboration, and personal growth drive meaningful impact for nonprofits around the world.

The Job

• Leverage multiple channels (e.g., LinkedIn Sales Navigator, calls, voicemails, and emails) to execute a high volume of outreach with strategy, creativity, and thoughtful persistence to reach key decision-makers.
• Facilitate qualifying calls and discovery sessions with high-level decision-makers, asking insightful questions to build relationships and showcase the value of GoFundMe Pro’s suite of tools.
• Execute creative engagement strategies provided by marketing, such as event outreach, mailers, and conference follow-ups, to drive account engagement.
• Methodically qualify, build, and manage a sales pipeline in Salesforce, with a focus on driving quality conversations that lead to strong deals.
• Accurately document and track all activities in Salesforce.
• Embrace emerging AI tools to enhance personalized outreach at scale and innovate as technology evolves.
• Balance a busy calendar of inbound and outbound priorities while staying focused on key initiatives that drive pipeline.
• Support multiple Account Executives by managing relationships, coordinating schedules, and contributing to diverse initiatives.
• Consistently exceed monthly quotas through hard work, proactive growth, and the implementation of feedback.
• Stay highly organized, adaptable, optimistic, and coachable while thriving in a fast-paced, evolving environment.
• Become an expert in online fundraising by understanding client needs, overcoming objections, and asking thoughtful questions.

You 

• 1+ years of inside tech sales or relevant experience (including nonprofit fundraising), preferably selling over the phone or web.
• Proven outbound prospecting experience.
• Excellent listening, verbal, and written skills, with the ability to craft thoughtful, engaging, and relevant communication for prospects.
• No fear of the phones! Confident speaking to prospects and handling objections.
• Skilled at navigating organizations to identify and connect with decision-makers.
• Growth mindset with a commitment to improving skills and adapting to change.
• High level of emotional intelligence to build and manage relationships effectively.
• Positive attitude, team player, and driven to win.
• Technically savvy, with the ability to learn and manage new tools competently. 

Preferred

• Bachelor’s degree (preferred but not required).
• Training or experience in consultative/value-based selling.
• Proficiency with CRM tools, preferably Salesforce.
• Experience with tools like Salesloft, 6Sense, LinkedIn Sales Navigator, or similar platforms.
• A proactive learner who seeks out opportunities for growth and takes feedback into action.
• A natural problem-solver who thrives on improving systems and processes.
• Excited by brainstorming and contributing new, creative outreach ideas.
• Committed to integrity, hard work, and maintaining high ethical standards.
• Assertive, persistent, and persuasive with strong listening skills—ready to show your grit.
• Motivated by surpassing goals and achieving excellence.
• Adaptable and resourceful, thriving in dynamic environments and handling challenges with confidence.
• Highly organized and detail-oriented, ensuring nothing “slips through the cracks.”

Why you’ll love it here

• Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
• Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
• Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
• Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
• Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
• Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
• Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
• Community Engagement: Make a difference through our volunteering program.

We live by our core values: impatient to be great, find a way, earn trust every day, fueled by purpose. Be a part of something bigger with us!

GoFundMe is proud to be an equal opportunity employer that actively pursues candidates of diverse backgrounds and experiences.  We do not discriminate on the basis of race, color, religion, ethnicity, nationality or national origin, sex, sexual orientation, gender, gender identity or expression, pregnancy status, marital status, age, medical condition, mental or physical disability, or military or veteran status.

The annual U.S. salary range for this full-time position is $69,500 - $104,500 which may include potential sales incentive payments. Your recruiter can share more about the specific OTE structure for this position during the hiring process. The company also offers equity and other benefits to employees, including healthcare, dental, vision, life insurance and 401(k) saving program. In addition to this wage, there are geolocation differentials that will increase pay depending on the work location. Additionally pay may vary depending on other factors including skills, experience, education, or training. Your recruiter can share more about the specific total compensation package based on your location during the hiring process.

If you require a reasonable accommodation to complete a job application or a job interview or to otherwise participate in the hiring process, please contact us at accommodationrequests@gofundme.com. 

Global Data Privacy Notice for Job Candidates and Applicants:

Depending on your location, the General Data Protection Regulation (GDPR) or certain US privacy laws may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required. 

Learn more about GoFundMe:

We’re proud to partner with GoFundMe.org, an independent public charity, to extend the reach and impact of our generous community, while helping drive critical social change. You can learn more about GoFundMe.org’s activities and impact in their FY ‘25 annual report.

Our annual “Year in Help” report reflects our community’s impact in advancing our mission of helping people help each other.

For recent company news and announcements, visit our Newsroom.

Notice to Applicants for Jobs Located in NYC or Remote Jobs Associated With Office in NYC Only

We use Metaview as part of our hiring process for jobs in NYC and certain features may qualify it as an automated employment decision tool (AEDT), as defined by New York City Local Law 144. As part of the hiring process, we provide Metaview with job requirements and candidate submitted resumes and application materials to assist in evaluating job-related qualifications. While this tool is used to improve efficiency and support our recruiting personnel, all final hiring decisions are made by GoFundMe employees.

We began using Metaview on March 10, 2026. The Metaview tool has been reviewed by an independent auditor. Results of the audit may be viewed here. The tool evaluates your professional experience, technical skills, education, and other qualifications using information collected directly from your submitted resume and application materials; all such data is retained in accordance with GoFundMe’s Personnel Privacy Notice and applicable legal requirements. If you would like to request an alternative selection process or a reasonable accommodation, please contact accommodationrequests@gofundme.com.