Senior Specialist, Quality Assurance
About The Position
The Senior Specialist, Quality Assurance is an individual-contributor, site-based role supporting the Foster City Manufacturing New Chess Facility (NCF). The position supports startup, operational readiness, and ongoing manufacturing and analytical operations, ensuring alignment with manufacturing, digital, quality control, and compliance priorities. The role provides Quality Assurance oversight for GMP operations and helps maintain product quality and compliance with applicable GMP and GLP requirements. The position reviews investigations and quality data, approves GMP documentation, supports audits and regulatory inspections, applies risk-based decision-making, and works with cross-functional partners on quality initiatives. It also provides leadership, development, and mentoring for Quality personnel and may provide on-call QA support to Manufacturing and QC operations as required.
Requirements
- At least 6 years of relevant experience in a GMP-related field with a BS or BA, or at least 4 years of relevant experience with an MS.
- Hands-on experience supporting biologics, GMP Manufacturing, and QC operations.
- Strong understanding of and experience with materials management, manufacturing, and analytical methods and testing systems in a GMP environment.
- Strong cross-functional collaboration and communication skills.
- Proficiency in GMPs and/or GLPs and in applying QA principles, concepts, industry practices, and standards.
- Ability to manage multiple projects and priorities effectively.
- Proven analytical and conceptual skills.
- Understanding of international quality systems regulations and ability to adopt best-in-class systems and processes.
- Excellent verbal communication, technical writing, and interpersonal skills.
- Working knowledge and good proficiency in Microsoft Office applications.
Nice To Haves
- Knowledge of Six Sigma, DMAIC methodology, performance measures, and quality improvement statistical methods.
- Working knowledge of risk management tools such as HACCP and/or FMEA.
Responsibilities
- Review and approve laboratory investigations, including OOS, OOT, and deviations, conducted by contract partners; ensure thorough root cause analysis, effective CAPAs, and aligned decisions affecting product quality and disposition.
- Apply Quality Risk Management principles and oversee risk assessments in collaboration with Manufacturing and QC operations.
- Participate in writing or revising controlled documents, such as SOPs, specifications, and methods, to meet quality objectives.
- Maintain programs and processes that support product quality and compliance with current GMPs and GLPs.
- Review manufacturing, environmental monitoring, and quality control data for in-process and finished products.
- Work with operating entities to ensure ongoing inspections, statistical process control analyses, and audits.
- May participate in developing training programs related to producing quality products.
- May conduct or coordinate investigations and recommend corrective and preventive actions related to manufactured products.
- Work with Research and Development during new product start-ups and establish checkpoints for new products and processes.
- May assist with or lead compliance audits and interface with regulatory agencies as required.
- Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
- Support regulatory inspections and internal audits; monitor regulatory requirements and proactively assess potential operational compliance risks.
- Approve GMP documentation, including risk assessments, procedures, master batch records, specifications, and analytical methods; drive continuous improvement of quality processes supporting GMP operations.
- Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
- Partner with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
- Lead or support Quality-related operational projects and improvement initiatives.
- Provide on-call Quality Assurance support to Manufacturing and QC operations as required.
- Use risk-based decision-making to prioritize tasks and ensure product quality.
- Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.
- Model inclusion, develop talent through coaching and feedback, and empower teams by aligning goals and helping remove barriers.
Benefits
- Discretionary annual bonus eligibility.
- Discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical insurance.
- Company-sponsored dental insurance.
- Company-sponsored vision insurance.
- Company-sponsored life insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
