The Sr. Specialist, External Quality Assurance is pivotal role within our Quality organization that offers a unique opportunity to shape our external QA framework as we scale from late-stage clinical operations to commercial launch. You will serve as the primary QA partner for our Contract Development and Manufacturing Organizations (CDMOs), providing rigorous oversight of cell banks, plasmids, Drug Substance, Drug Product, and Finished Drug Product. We are seeking a proactive QA professional with a track record of driving cross-functional alignment, managing external vendor relationships, and supporting successful regulatory submissions/approvals.
Responsibilities- External Operations Oversight: Drive QA oversight for external CDMO operations, technical transfers, and analytical testing laboratories across both clinical and commercial supply chains.
- Batch Disposition & Review: Provide comprehensive review of GMP related documentation including batch records, packaging/labeling documentation, sampling plans, specifications, and testing protocols to ensure full cGMP compliance.
- Complex Investigations: Partner with Manufacturing, Process Sciences, Supply Chain, and QC to investigate and resolve deviations, non-conformances, and CAPAs prior to batch disposition.
- Change Governance: Review and manage change controls and quality events for process, equipment, facility, and method modifications-ensuring commercial readiness and compliance.
- QMS Implementation & Evolution: Author and refine Quality SOPs while contributing to the continuous expansion of site Quality Systems, tracking key quality metrics, and presenting performance trends to leadership.
- Cross-Functional Leadership: Serve as the QA voice on cross-functional teams, offering clear, risk-based compliance guidance and regulatory alignment.
- Supplier Management & Inspection Readiness: Support onboarding and lifecycle management of suppliers, internal/external audits, and regulatory inspection preparations as we prepare for commercial approval.
RequirementsCore Qualifications:- Education: Bachelor's degree in a scientific or life sciences discipline (e.g., Biology, Chemistry, Biochemistry).
- Experience: 7+ years of progressive QA experience in a cGMP-regulated biotechnology environment.
- Clinical & Commercial Breadth: Demonstrated experience supporting late-stage clinical manufacturing, commercial quality operations, and tech transfers.
- Regulatory Acumen: Deep working knowledge of cGMP standards, international regulations, and regulatory guidance documents (21 CFR Parts 210/211/11, USP, EP, ICH).
- Problem-Solving & Collaboration: Outstanding ability to lead complex cross-functional root-cause investigations and translate technical challenges into actionable compliance recommendations.
- Mindset: Autonomous self-starter capable of navigating a dynamic, fast-paced environment while maintaining complete objectivity in quality decision-making.
Preferred Qualifications:- Direct experience with AAV, viral vectors, or gene therapy platforms.
- Direct exposure to a successful BLA/MAA filing, regulatory inspection, or commercial drug approval process.
- Hands-on experience with electronic Quality Management Systems, specifically Veeva Quality Vault.
Benefits- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time, and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Stocked micro-kitchen with drinks and snacks
- Wellness Resources
