What are the responsibilities and job description for the Senior Director Quality position at Meet?
Location: South San Francisco
Industry: Biotechnology | Cell & Gene Therapy
Employment Type: Full-time
Are you a seasoned Quality leader with deep expertise in GMP, GCP, and GLP compliance? Do you have experience with biologics, cell therapy, or gene therapy and a track record of successfully leading quality assurance and quality control functions? If so, this opportunity could be an exciting next step in your career!
Our client, an innovative clinical-stage biotech company, is seeking a Sr. Director or Vice President of Quality Assurance & Quality Control to lead and scale their quality function. This role will oversee end-to-end quality management, ensuring regulatory compliance, continuous improvement, and best-in-class QA/QC strategies across GMP manufacturing, clinical development, and preclinical research. The selected candidate will also serve on the senior leadership team and present to the board of directors.
Key Responsibilities:
- Quality Leadership: Lead the development and execution of QA/QC strategy across GMP, GCP, and GLP functions.
- Regulatory Compliance: Ensure adherence to FDA, EMA, ICH, and global regulatory requirements for clinical-stage programs.
- GCP Oversight: Provide QA leadership for clinical trials, ensuring data integrity and compliance with GCP guidelines.
- GMP & QC Management: Support internal GMP manufacturing, QC testing, and vendor oversight for contract manufacturing/testing partners.
- Audits & Inspections: Lead regulatory inspections, internal audits, and quality risk management initiatives.
- SOP & QMS Development: Implement and maintain robust Quality Management Systems (QMS) and SOPs aligned with regulatory requirements.
- Cross-Functional Collaboration: Work closely with Clinical Operations, Regulatory Affairs, Manufacturing, and R&D teams to drive quality initiatives.
- Senior Leadership & Board Presentations: Serve as a key advisor on quality strategy and regulatory compliance, reporting to executive leadership and the board of directors.
Key Qualifications:
- 18 years of industry experience, with at least 5 years in a senior leadership role.
- Strong expertise in GCP, GMP, and GLP regulations with proven leadership in a clinical-stage biotech environment.
- Experience with biologics is required; cell or gene therapy is highly preferred.
- Proven track record of leading quality assurance teams and implementing quality systems in a fast-paced, high-growth environment.
- Regulatory inspection and audit leadership experience (FDA, EMA, ICH compliance).
- Strategic mindset with the ability to manage risk, drive process improvements, and scale quality operations.
- Strong interpersonal and leadership skills, with the ability to collaborate across departments and influence key stakeholders.
- Experience with stage-appropriate QA/QC for early clinical development is highly desirable.
Why Join?
- High-impact leadership role within a cutting-edge biotech company.
- Opportunity to build and shape the quality function in a fast-growing organization.
- Board-level visibility and influence over clinical development and GMP manufacturing strategy.
- Competitive compensation package and strong growth potential.
Interested? Apply now or reach out to learn more!
