Senior Director, Quality Assurance

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee quality assurance activities related to method validation, release, and in-process testing for Drug Substance and Polysaccharide.

• Act as the primary point of contact within Vaxcyte QA and with external collaborators, fostering partnerships that address analytical requirements for relevant programs.

• Represent the QA team in both internal and external cross-functional team meetings.

• Lead the review and approval of GMP documentation, both internal and external, ensuring compliance with specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs related to polysaccharides and drug substances; utilize technical and compliance expertise to thoroughly evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.

• Collaborate with QC, vendor management, and contract laboratories to establish key performance indicators for assessing vendor effectiveness.

• Facilitate the resolution of quality performance issues with contract manufacturers and testing organizations.

• Review Quality Agreements and regulatory documentation as necessary.

• Lead investigations into quality issues related to testing deviations and OOS.

• Contribute to regulatory submissions, addressing inquiries from health authorities, and ensuring the quality of documentation supporting regulatory filings.

• Participate in audit preparations and assist in maintaining ongoing readiness.

• Develop, review, and update internal GMP-related policies and procedures as needed.

• Promote a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving the implementation of sustainable solutions, and establishing performance standards that enhance GMP compliance across internal teams and external partners.

⛳️ Requirements

• A Bachelor’s degree in Biochemistry, Chemistry, or a related field, complemented by over 15 years of relevant industry experience. Alternative combinations of education and/or experience may be considered.

• In-depth knowledge of FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with demonstrated expertise in applying these regulations to create practical solutions and phase-appropriate analytical strategies.

• Experience in biochemistry, immunoassay, or microbiological assay techniques within a Quality Control setting.

• Strong organizational and project management abilities, capable of managing multiple projects within tight timelines.

• Exceptional written and verbal communication skills, with the capacity to work effectively in cross-functional teams.

• Prior experience in the validation and transfer of analytical assays.

• Proven track record of building and developing high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced biotech environment.

• Familiarity with Risk Management principles.

• Knowledge of both clinical and commercial products is preferred.

• Ability to integrate and interpret interdisciplinary project information, possessing at least a high-level understanding of the drug/vaccine development process.

• Capacity to collaborate globally with CMOs across different countries and continents.

• Experience managing geographically dispersed QA teams across multiple sites or countries, with a focus on establishing a cohesive quality culture and consistent GMP standards across locations.

• Experience with BLA submissions and commercial launches is highly desirable.

🏝️ Benefits

• The compensation package will be competitive and includes comprehensive benefits along with an equity component.