PurposeThis position is within the Product Development Quality Assurance (PDQA) organization and supports the timely review and disposition of batch documentation to help ensure uninterrupted clinical supply, advance the R&D pipeline, and maintain compliance with AbbVie standards and global GMP requirements. The role supports New Biological Entities (NBE), New Chemical Entities (NCE), and Advanced Therapy Medicinal Products (ATMP) across all phases of development, partnering with Third Party Manufacturers (TPM), AbbVie commercial manufacturing sites, and cross-functional teams to ensure drug substance and drug product for clinical use meet quality and regulatory requirements.
Job DescriptionThe Senior R&D Quality Officer is responsible for GMP batch documentation review and clinical supply disposition for NBE, NCE, and ATMP development programs. This role applies deep QA expertise and GMP knowledge to ensure quality oversight of manufacturing activities at TPMs and AbbVie commercial sites in accordance with global GMP requirements and AbbVie quality standards. The role also provides strategic quality leadership, cross-functional influence, and support for development and mentoring of junior PDQA quality staff.
Key responsibilities include, but are not limited to:
- Works effectively in a global environment, supporting the global Quality Assurance organization and cross-functional teams across multiple regions and time zones.
- Review and approve batch manufacturing records (master and executed) and quality documentation for drug substance and drug product clinical supply batches at TPMs and AbbVie sites; make batch disposition and quality release decisions per SOPs, quality agreements, and GMP requirements; and apply risk-based quality assessments to support timely, defensible decisions and clinical supply continuity.
- Assess the quality impact of manufacturing changes affecting drug substances or drug products, with a focus on NBE/NCE/ATMP clinical supply programs.
- Author, review, and approve quality system documents, including SOPs and manufacturing instructions, to ensure accuracy and sustained GMP compliance.
- Lead deviation and investigation activities for documentation errors, batch discrepancies, and process failures; author, review, and approve deviation/change control plans, exception documentation, and CAPA plans; drive thorough root cause analysis, timely corrective action, and sustained batch record right-first-time improvements.
- Support the development of quality agreements with TPMs and internal manufacturing sites; lead TPM and supplier quality oversight activities, including escalation, and qualification strategy discussions.
- Provide quality approvals in materials management and electronic quality systems, ensuring traceability, data integrity, and compliance across the clinical supply chain.
- Partner cross-functionally with Clinical Drug Supply Management, Development Sciences, and Operations to identify and mitigate quality and manufacturing risks early in the batch lifecycle, protect batch availability, and ensure clinical supply continuity; lead project team efforts to drive timely, risk-based resolution strategies.
- Generate, monitor, and report key PDQA quality metrics including batch documentation cycle times, aging documents, deviation trends, repeat deviations, CAPA effectiveness, and release blockers; present data-driven findings and improvement recommendations to PDQA management.
- Support inspection readiness activities, including document retrieval, participation in mock audits, and coordination of QA-related responses; ensure the PDQA function maintains a perpetual state of inspection readiness.
- Contribute to continuous improvement initiatives that strengthen GMP compliance, reduce review burden, and improve the overall reliability and quality oversight of clinical supply operations.
- Provide mentoring and informal training to newer QA staff and cross-functional partners on batch documentation standards, GMP expectations, and quality system requirements; provide formal development support to junior PDQA colleagues.
Qualifications- Bachelor's degree required, preferably in Biology, Chemistry, Biochemistry, Pharmacy, or Chemical Engineering; advanced degree (M.S. or Ph.D.) may be considered in lieu of experience.
- 4-6 years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or related life sciences industry; 8+ years preferred. Clinical supply, GMP manufacturing and Quality Assurance experience strongly preferred.
- Working knowledge of global GMP requirements for drug substance and drug product manufacturing across biologics, small molecules, and ATMPs, including ICH Q7, ICH Q10, 21 CFR Parts 210/211, and relevant EU GMP Annexes.
- Demonstrated experience reviewing and approving complex GMP batch records and associated quality documentation; familiarity with electronic batch record and quality management systems is a strong asset.
- Proven ability to manage multiple competing priorities in a dynamic, fast-paced development environment, maintaining rigorous attention to detail and consistently meeting disposition timelines critical to clinical trial supply.
- Experience with TPM quality oversight, including supplier qualification, quality agreements, and performance monitoring.
- Strong communication and interpersonal skills, with the ability to articulate quality positions, influence cross-functional decisions, and partner effectively across levels.
- Demonstrated problem-solving skills, with the ability to apply technical knowledge and sound quality judgment to independently resolve complex GMP issues, including time-sensitive situations impacting patient supply.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
