Director, GMP Quality Assurance

Overview

Meet is working with a clinical stage biotechnology company looking to hire an Associate Director/Director of GMP Quality Assurance. Reporting to the Head of Quality, you will work with cross-functional teams to manage external vendors and CDMOs. The role involves providing quality support and contributing to the development of quality systems. Expertise in GMP and related regulations is required.

Base pay range

$170,000.00/yr - $240,000.00/yr

Responsibilities

• Serve as the technical expert on CGMP-related regulations and guidelines, specifically for manufacturing, testing, and controls.
• Review and approve drug substance and drug product manufacturing, packaging, and labeling documents within defined timelines.
• Lead and support external quality activities, including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits.
• Participate in CDMO team meetings, providing quality feedback and collaborating on complex investigations for the company's global product network.
• Ensure collection, review, and analysis of data for internal and external metrics.
• Offer guidance, review, and impact assessments for change controls and CAPAs.
• Assist in the implementation of CGMP and GLP activities in line with internal procedures and regulatory requirements.
• Participate in quality system and product review meetings, providing quality reviews of key CMC and IND documents and ensuring data integrity compliance.
• Represent Quality on project teams, Health Authority inspections, supplier and CDMO meetings, and QA-to-QA discussions.
• Work with Quality Person (QP) to support key document development and approval.
• Opportunity to gain hands-on experience with GCP-focused projects, including the potential to participate in auditing activities.
• Foster a strong quality mindset and excellence across the organization.

Education & Professional Experience

• Bachelors or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field.
• Minimum 5 years of CGMP Quality Assurance experience.
• Knowledge in clinical development to commercial is desired (ideally phase II/III to commercial).

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Biotechnology; Research and Pharmaceutical Manufacturing

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