Job description
Location: San Francisco Bay Area
Company Overview:
Our client is a late-stage biotechnology company developing transformative therapies for cardiometabolic and obesity-related diseases. With multiple programs advancing through pivotal stages of development and internal laboratories supporting discovery and translational work, the company is committed to scientific excellence and improving outcomes for patients with serious chronic conditions.
The Director, GLP Quality will lead the development, implementation, and oversight of the company’s GLP Quality Management System, ensuring compliance across all nonclinical and bioanalytical activities performed internally and at external partners. This individual will play a critical role in shaping quality strategy, inspection readiness, and continuous improvement for a rapidly scaling organization.
Key Responsibilities:
Qualifications:
Additional Details:
Company Overview:
Our client is a late-stage biotechnology company developing transformative therapies for cardiometabolic and obesity-related diseases. With multiple programs advancing through pivotal stages of development and internal laboratories supporting discovery and translational work, the company is committed to scientific excellence and improving outcomes for patients with serious chronic conditions.
The Director, GLP Quality will lead the development, implementation, and oversight of the company’s GLP Quality Management System, ensuring compliance across all nonclinical and bioanalytical activities performed internally and at external partners. This individual will play a critical role in shaping quality strategy, inspection readiness, and continuous improvement for a rapidly scaling organization.
- Serve as the company’s GLP Quality leader and primary QA representative for all GLP-regulated and GCLP-compliant activities.
- Establish, maintain, and continuously improve a risk-based GLP Quality System supporting internal and outsourced laboratory operations.
- Partner closely with Nonclinical, Bioanalytical, and Translational Sciences teams to ensure data integrity, regulatory compliance, and scientific rigor.
- Lead regulatory inspection preparation and hosting, including direct interaction with global health authorities (FDA, EMA, MHRA, etc.).
- Oversee vendor qualification, auditing, and ongoing oversight of GLP/GCLP labs and CRO partners.
- Develop, review, and approve SOPs, quality policies, and technical documentation relevant to GLP compliance.
- Manage the CAPA, deviation, and change control programs related to nonclinical and laboratory operations.
- Provide training, mentoring, and guidance to laboratory and QA staff on GLP expectations and best practices.
- Collaborate cross-functionally to ensure alignment between research, development, and quality goals.
- Drive continuous improvement initiatives and implement scalable quality systems as the organization prepares for commercialization.
- Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field); advanced degree (MS, PhD) preferred.
- 10+ years of GLP Quality Assurance experience in the biopharmaceutical industry, including oversight of internal and external labs.
- Strong understanding of FDA, OECD, and global GLP regulations and GCLP expectations.
- Demonstrated success preparing for and leading regulatory inspections and sponsor audits.
- Hands-on experience developing and managing QA systems for nonclinical and bioanalytical operations.
- Proven ability to build collaborative relationships across R&D and Quality functions.
- Excellent organizational, communication, and leadership skills with the ability to influence across teams.
- Experience in cardiometabolic, endocrine, or metabolic disease areas strongly preferred.
- Reports to: Head of Quality
- Travel: ~20% (domestic and international, as required)
- Environment: Hybrid onsite in the Bay Area