Job Summary

The Manager of Quality Assurance will provide strategic quality oversight for outsourced drug substance, drug product, and/or quality control (QC) testing operations in support of biologics programs. Operating within a fully outsourced, “virtual company” model, this individual will be responsible for ensuring that Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) perform activities in compliance with global GMP requirements and quality agreements. The Manager of Quality Assurance will serve as a primary quality interface between internal stakeholders and external partners, ensuring product quality, regulatory compliance, and inspection readiness.

Job Responsibilities

Oversight of External Manufacturing and Testing

• Provide QA oversight for CDMOs and CTLs involved in biologics manufacturing, packaging, labeling, and QC testing.
• Review and approve batch records, testing results, Certificates of Analysis, and release documentation for drug substance and/or drug product.
• Monitor compliance with quality agreements, ensuring third parties adhere to contractual and regulatory obligations.

Quality Systems & Compliance

• Review and approve deviations, CAPAs, change controls, and investigations originating at CDMOs/CTLs, ensuring alignment with corporate standards and global regulations.
• Ensure robust root cause analysis and effective CAPA implementation to prevent recurrence.
• Oversee data integrity compliance and enforce adherence to industry best practices (ALCOA+ principles).

Regulatory Support

• Maintain and apply up-to-date knowledge of global regulatory requirements (FDA, EMA, MHRA, Health Canada, PMDA, WHO, PIC/S, ICH).
• Partner with Regulatory Affairs to ensure inspection readiness and provide quality input to regulatory submissions (IND, BLA/MAA, variations).
• Participate in audits of CDMOs and CTLs; support and lead regulatory inspections as the quality representative for outsourced operations.

Strategic and Cross-functional Partnership

• Serve as the primary QA point of contact for outsourced operations, facilitating collaboration with internal Manufacturing, QC, Regulatory, and Supply Chain functions.
• Provide guidance and training to internal stakeholders on quality and compliance in a virtual company model.
• Identify and drive continuous improvement initiatives across the QA function and within partner relationships.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, or related field.
• 7+ years of QA experience in biologics or pharmaceutical industry, with exposure to outsourced/virtual company environments.
• Deep knowledge of cGMP and global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, ICH, PIC/S, WHO).
• Proven experience overseeing including batch release, deviation investigations, and change control.
• Demonstrated success in supporting regulatory inspections and preparing audit responses in collaboration with external partners.
• Strong interpersonal skills with the ability to influence and collaborate across organizational and cultural boundaries.
• Experience with electronic quality systems (e.g., Veeva) and strong proficiency in data integrity standards.

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $135,000 - $145,000 per annum

Special Advisory 

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