Senior Director, Quality Assurance

Senior Director, Quality Assurance

W2 Contract

Pay Rate: $100 - $140 per hour

Location: South San Francisco, CA - Onsite Role

Job Summary:

The Senior Director, Quality Assurance, provides strategic and hands-on QA leadership for our clinical-stage oral recombinant tablet vaccine programs and related GMP manufacturing, testing, and CMC activities. Reporting to the Chief Technology Officer, this leader is responsible for implementing and maintaining phase-appropriate quality systems that support compliant development, manufacture, testing, release, and supply of investigational products.

Duties and Responsibilities:

• Lead implementation and day-to-day execution of GMP quality management systems supporting oral recombinant tablet vaccine development and manufacturing.
• Ensure compliance with applicable FDA, EMA, ICH, and other global GMP regulations, standards, internal policies, and procedures.
• Develop, implement, and monitor progress against strategic quality plan, quality objectives, projects, and goals in alignment with CMC and program priorities.
• Provide QA oversight of GMP manufacturing, analytical testing, stability, labeling, packaging, and release of clinical supplies for investigational oral tablet vaccine products.
• Review and approve Master Batch Records (MBRs), executed batch records, specifications, protocols, reports, change controls, deviations, investigations, CAPAs, and related documentation to ensure accuracy, completeness, data integrity, and cGMP compliance.
• Conducts and supports internal and external audits, GMP supplier qualification activities, including CDMOs, contract testing laboratories, raw material suppliers, and other contractors.
• Review and approve laboratory investigations (OOS/OOT/deviations) conducted by internal or external laboratories, ensuring thorough root cause analysis, robust corrective and preventative actions (CAPA), and aligned decision-making impacting product quality and disposition.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, data integrity, and supply continuity.
• Ensure risk-based quality decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
• Review executed batch records and supporting documentation for lot disposition, ensuring completeness, accuracy, and compliance with cGMP requirements, and confirming that all deviations, investigations, and quality events are appropriately resolved prior to batch release.
• Support regulatory submissions, health authority questions, inspection readiness, regulatory inspections, and responses to inspection observations related to GMP manufacturing and quality systems.
• Review and approve stability protocols, reports, specifications, and supporting data to ensure study design, data integrity, and conclusions are scientifically sound, compliant with cGMP and regulatory expectations, and supportive of product shelf life and storage conditions.
• Oversee and implement Quality Systems to ensure compliance with cGMP activities company-wide.
• Controls the issuance and revision of Standard Operating Procedures, including, but not limited to, Quality Manual, Policies, Batch Records, and Protocols.
• Manages the implementation and operation of a document management system.
• Drive continuous improvement of phase-appropriate quality systems, including deviation, CAPAs, change controls, supplier quality, complaints, product disposition, and management review processes. Represent Quality with involved external regulatory and standards bodies (e.g., Food and Drug Administration, ISO assessors, etc.) when necessary to help adjudicate issues with product submissions, product performance, compliance concerns, and prevailing/impending regulatory requirements.

Requirements and Qualifications:

• Bachelor's degree and 15 years of experience or a master's degree with 12+ years of experience in a scientific discipline or comparable experience.
• 10+ years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
• Experience with all phases of development (Ph 1-4, including commercial).
• In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product-related guidelines, and other ICH guidelines.
• Demonstrated ability to interpret regulations, apply phase-appropriate quality expectations, and make sound risk-based quality decisions.
• Prior managerial responsibility leading teams and cross-functional work.
• Experience preparing for, supporting, and responding to regulatory authority inspections, partner audits, and other audits.
• Hands-on experience reviewing batch records, CoAs, deviations, investigations, CAPAs, stability documents, specifications, change controls, and GMP protocols and reports.
• Strong technical writing, investigative, root cause analysis, and risk-assessment skills.
• Familiarity with electronic QMS platforms (e.g., Veeva QMS, MasterControl, TrackWise).
• Ability to work effectively in a small-company, fast-paced, matrixed environment with shifting priorities.
• Proficient in organization, prioritization, and time management, and able to manage multiple priorities.
• Excellent verbal, written, interpersonal, influencing, organizational, and stakeholder-management skills.
• Strong commitment to product quality, patient safety, compliance, scientific rigor, and attention to detail.
• Strategic thinker with a hands-on approach and proven ability to balance long-term quality planning with day-to-day execution.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.