Sr QA Reviewer, Biologics Approval

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description Job Title: Sr. QA Reviewer Analytical Quality Assurance Oversight - Biologics This is a fully onsite role based at our customer’s site in Foster City, CA . We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. Job Summary: The Senior QA Reviewer will provide quality assurance lifecycle support for analytical testing activities, with a primary focus on oversight of method transfers, qualifications, validations, investigations, and risk assessments conducted by external partners. This role requires a strong compliance-driven QA professional who can independently review technical documentation, challenge scientific rationale when appropriate, and support GMP quality operations. Key Responsibilities: · Provide QA support and oversight for analytical testing activities across the biologics product lifecycle, from cell bank through drug product. · Support oversight of external laboratories and analytical method lifecycle activities (qualification, verification, validation) to ensure compliance with cGMP, ICH, and internal quality standards. · Review and support approval of analytical methods, protocols, reports, and laboratory investigations (e.g., deviations, OOS, OOT). · Partner with QC, Manufacturing, and cross-functional teams to assess analytical risks, resolve quality issues, and support product quality decisions. · Apply Quality Risk Management principles to support risk assessments and ensure appropriate documentation and compliance. · Evaluate documentation generated by external testing partners. · Review laboratory investigations resulting from routine testing events. · Assess root cause analyses and investigation conclusions. · Provide QA feedback and recommendations. · Partner with QC leadership to develop appropriate remediation and path-forward strategies. · Apply Quality Risk Management (QRM) principles to analytical and quality systems activities. · Review and support risk assessments associated with method transfers, validations, and related quality events. · Ensure risk-based decision-making is scientifically justified and compliant. · Review GMP documentation including procedures, risk assessments, analytical methods, protocols, and reports. · Assist with regulatory inspections, audits, and responses to observations as needed. · Maintain working knowledge of FDA, Health Canada, ICH, and global GMP requirements relevant to biologics analytical testing. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’) OR Masters degree and 2+ years of above related experience Minimum 4+ years of relevant QA experience. Strong background in Analytical Quality Assurance or Analytical Development QA. Experience providing QA oversight for GMP QC operations. Biologics industry experience required, including: Drug Substance (DS), Drug Product (DP) or Cell Bank activities Experience reviewing documentation generated by external contract laboratories or testing organizations. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Technical & Quality Mindset · Strong GMP and compliance focus. · Ability to critically review technical documentation. · Comfortable challenging technical counterparts when: · Scientific rationale is unclear. · Potential compliance or quality concerns are identified. · Demonstrates independent thinking and sound quality judgment. Organizational & Communication Skills · Highly organized and capable of managing fluctuating workloads. · Self-starter who works independently with minimal direction. · Excellent verbal and written communication skills. · Proactive in identifying and escalating quality concerns. Systems & Tools · Experience with Veeva Vault preferred. · Role will primarily function as a reviewer within Veeva Vault. · Experience working within document review workflows, including offline review processes, is beneficial. Working Environment: Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects