Senior Director, Quality Assurance (GMP)

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Salary: $220,000 - $260,000 per year

We are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.

Competitive Salary

Annual Bonus

Equity

ESPP

401k Program

Medical/Vision/Dental

Hybrid Schedule

We are looking for a Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing.

You must be an expert in biologics, specifically operational QA experience with monoclonal antibodies, and have a strong background partnering with external manufacturers.

Hybrid Position requires 3 days per week on site

Responsibilities:

• Provide quality support and guidance for our CMC programs
• Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers.
• Provide quality oversight GMP suppliers
• Extensive document review and approval for: master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports, release testing COAs and reports, etc.
• Review and support GMP investigations associated with lot-related deviations,
• Review change controls, CAPAs, OOS/OOT investigations
• Perform lot disposition
• Ensure that GMP quality documentation is securely archived and retrievable.
• Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions.
• Contribute to the development of our QMS as needed
• Ensure inspection readiness at our GMP suppliers
• Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests
• Continuous improvement of quality and compliance practices to ensure highest standards are maintained.
• Approximately 10-20% travel (domestic and international)

Qualifications:

• Bachelor’s degree in a scientific field
• 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
• Expertise in biologics is required
• In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
• Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
• Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously

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