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About the Role
The Senior Manager, Quality Assurance – Drug Product provides quality oversight for outsourced drug product manufacturing, packaging, labeling, testing, release, and distribution for clinical-stage and late-phase programs. This role serves as the primary QA representative for CDMOs and testing laboratories, ensuring GMP compliance and inspection readiness.
Responsibilities
- Serve as the QA lead for drug product CDMO oversight across manufacturing, testing, packaging, labeling, and release activities.
- Provide real-time QA support for manufacturing campaigns, including batch disposition, deviation management, laboratory investigations, and change control.
- Review and approve GMP documents such as master batch records, protocols, reports, and specifications.
- Oversee and resolve deviations, investigations, CAPAs, and change controls.
- Act as the primary QA interface with CDMOs to maintain quality oversight and compliance.
- Participate in vendor selection, qualification, and performance management, including audits and quality agreements.
- Collaborate cross-functionally with Analytical Development, QC, Manufacturing, Regulatory Affairs, and Supply Chain.
- Support regulatory inspections and filings to ensure documentation is inspection-ready.
- Contribute to the development and improvement of quality systems and best practices for external manufacturing.
- Mentor QA team members and contribute to building a high-performing organization.
- Support risk management activities to mitigate quality and supply risks.
- Participate in internal audits and health authority inspections as a subject matter expert.
- Provide QA support to early-phase programs to ensure scalability and consistency.
- Support blinded and unblinded clinical supply operations, including review of labeling and packaging controls.
- Stay current with regulatory requirements and industry trends related to GMP and ICH guidelines.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
- 8+ years of experience in the pharmaceutical or biotechnology industry.
- Significant experience in Quality Assurance.
- Strong knowledge of FDA, EMA, MHRA, ICH, and global GMP regulations.
- Experience supporting batch disposition and release activities for clinical products.
- Proven experience overseeing CDMOs and external manufacturing networks.
- Working knowledge of EU Qualified Person (QP) certification and batch release requirements.
- Experience with deviation investigations, laboratory investigations, change control, CAPA management, and risk management.
- Ability to manage multiple priorities in a fast-paced environment.
- Ability to travel up to 20–30% domestically and internationally.
Skills
- Quality Assurance
- GMP compliance
- CDMO oversight
- Batch disposition
- Deviation management
- CAPA management
- Risk management
- Cross-functional collaboration
- Leadership and mentoring
- Problem-solving
- Communication
Location
- California
- Shanghai
Work Type
- Full-time
Experience Level
- 8+ years
Education Level
- Bachelor’s degree
Salary/Compensations
- $162,000 - $189,000
Benefits
- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401k match
- Unlimited PTO
- Paid holidays including winter shutdown
About the Company
- Structure Therapeutics develops life‐changing medicines using advanced structure‐based and computational drug discovery technology.
- The company focuses on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
- Led by international drug innovators and financed by top-tier global life sciences investors.
- Publicly traded company (IPO February 2023).
Equal Opportunity
- Structure Therapeutics Inc. is an Equal-Opportunity Employer.