What You'll Do

The Manager/Senior Manager, QA Operations will serve as the primary quality owner for commercial packaging operations at assigned contract service providers (CSPs). You will ensure GMP compliance across day-to-day operations, manage batch record review and disposition activities, and serve as the quality partner to internal and external stakeholders. The ideal candidate brings expertise in commercial packaging and release operations, with a background that includes process validation and product launch support.

Responsibilities

• Serve as the quality lead for commercial packaging operations at assigned CSPs, providing oversight across primary/secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.

• Review executed batch records and compile batch documentation packages to support lot disposition and market release.

• Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.

• Review and provide quality input on tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.

• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution

• Support review of CMC sections and regulatory filings.

• Author, review, and maintain QA Operations SOPs and controlled documents.

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor’s degree in a scientific discipline with 6+ years of experience within a biopharmaceutical company and at least 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.

• Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities.

• Experience with Veeva platform highly preferred.

• Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.

• Ability to exercise good judgment and make decisions that align with organizational objectives.

• Results-driven mindset, taking initiative and ownership of assigned tasks.

• Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment.

• Commitment to continuous improvement and embracing innovative approaches in daily work.

• Up to 15% domestic and international travel required.

What You'll Do

The Manager of QA Compliance, reporting to the Director, QA Compliance, responsible for the development, review, execution, and maintenance of the Quality Agreement.  Support internal and external audit operations, inspection readiness, and compliance metrics. This role requires strong cross-functional collaboration with CMC, Quality Control, Supply Chain Management, Regulatory Affairs, Legal, Contract Service Providers, and other functional areas as needed.

Responsibilities

• Lead and manage global Quality Agreements/QTAs by developing, reviewing, executing, and maintaining agreements, ensuring compliance with the scope of services, regulatory requirements, internal standards, and all terms and conditions
• Collaborate with internal cross-functional teams and external stakeholders (e.g., contract service providers) to bring Quality Agreements to an approvable state
• Track Quality Agreement renewal and revision cycles
• Support regulatory authority inspection readiness activities at CSP and internally
• Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards
• Participate in the planning of internal audits
• Ensure audit findings are followed up on, corrective actions are completed, implemented, and verified to ensure compliance
• Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation
• Maintain master vendor list with up-to-date Health Authority certification/licenses
• Maintain risk registers and communicate risk trends to Quality leadership
• Develop, track, analyze, and present Quality Compliance metrics, including audit data, CAPA performance, Quality Agreement KPIs, risk assessments, and vendor performance indicators
• Prepare quality dashboards and monthly/quarterly reports for management review
• Support SOP development and revision related to Quality Agreements, auditing, risk management, and metrics
• Other duties as assigned

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's degree in a scientific discipline; an advanced degree is a plus
• A minimum of 8+ years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Hands-on experience drafting commercial Quality Agreements with various scopes of services
• Prior experience in vendor qualification processes
• Excellent communication, relationship-building, and technical writing skills
• Strong knowledge of global GxP regulations (FDA, EMA, ICH)
• Prior experience in leading/supporting PAI readiness activities
• Ability to work in a virtual environment
• Ability to thrive in a dynamic, fast‑paced, cross‑functional environment
• Willingness to travel both domestically and internationally as required

#LI-NT1

What You'll Do

Manage lot release activities at the company’s Contract Manufacturing  Organizations (CMOs). The individual will act as QA Operations lead with assigned CMOs, including  review of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Sr. Manager, QA Operations - Product Release will ensure that the CMO SOPs and Master Batch Records are in compliance with cGMPs and will serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed. 

Responsibilities

• Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance
• Review and manage master and executed manufacturing batch records from CMOs, including release activities, and  related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports
• Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
• Lead disposition of Drug Substance (DS), Drug Product (DP) and Finished Product (FP)
• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
• Support review of regulatory filings
• Support audit of CMOs

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization
• Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA), ICH and GxP principles
• General knowledge of FDA and other global clinical trial regulations
• Prior experience in QC, Analytical Development and process validation highly desired
• Excellent verbal and written communication skills, with a strong customer focus
• Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
• Travel up to 10% total time
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

#LI-SG1