À propos de ce poste Sr. Manager Quality Control, EU chez Acadia Pharmaceuticals Inc.
Position Summary:
The Sr. Manager, Quality Control EU plays a key role in the quality direction of analytical methods and specifications used to test and release Acadia’s products outside North America. This position is responsible for the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that is conducted at multiple Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs) as well as the review of analytical method validations/transfers between laboratories outside North America. The role is responsible for the analytical review of release testing and stability data of DS and DP and coordinates efforts with CSPs to report and trend analytical test results in a timely manner. The position supports the quality review of analytical technical reports and documents intended for regulatory submissions.
Primary Responsibilities:
- Review and approve analytical test results for DS and DP
- Review and/or author analytical method protocols, validations and analytical sections of annual product quality reviews for commercial products
- Review and/or author analytical transfer protocols and reports between laboratories
- Author stability protocols and reports
- Negotiate stability related agreements
- Actively monitor stability programs at CSPs
- Author and/or review analytical data summaries to support batch release and stability assessments
- Assist in the review of reports for regulatory filings
- Support and participate as needed during inspections of local health authorities
- Direct CSPs to facilitate stability testing at contract laboratories for Acadia projects
- Coordinate stability studies including reporting of test results
- Report stability data/trending to senior management
- Liaises with manufacturing, quality and regulatory counterparts to develop stability protocols for regulatory submissions
- Liaises with project teams to identify intermediates, DS and DP batches required to be added to stability programs
- Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines
- Lead analytical data review at CSPs
Education/Experience/Skills
- Bachelor’s degree in a Health Science discipline required, Master’s degree preferred. Equivalent combination of relevant education and applicable job experience will be considered.
- Minimum 3-5 years of experience within the pharmaceutical manufacturing industry with focus on quality control/quality assurance
- Strong knowledge of EU, JP, and FDA GMP regulations, ICH guidelines as well as other relevant regulatory requirements
- Proven experience managing outsourced GMDP activities
- Strong organizational and project management skills with the ability to manage multiple projects simultaneously
- Excellent attention to detail and commitment to quality.
- Effective negotiation and stakeholder management skills.
- Ability to independently assess complex situations, resolve issues, and recommend practical solutions.
- Strong risk-based decision-making and problem-solving capabilities.
- Excellent written and verbal communication skills with the ability to convey complex information to diverse audiences
- Demonstrated ability to build collaborative relationships and work effectively across functions and external partners with flexible working hours.
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 9 kilograms. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
