Quality Assurance Operations Consultant

Consultant, GMP Quality Operations

12-month contract

Part-time 3-4 days a week

Candidate is required to reside on the east coast East Coast

We are seeking a highly skilled and experienced Consultant, GMP Quality Operations to oversee and ensure the highest standards of quality in our contract manufacturing and contract testing organizations. In this role, you will be responsible for managing the production, validation, testing, and disposition of commercial and investigative products for use in clinical trials.

Responsibilities:

• Oversee and review GMP supplier audits.
• Provide quality oversight for contract manufacturing operations of drug substance and drug product, both for commercial and clinical trial materials.
• Provide quality support on tech transfers.
• Conduct GMP and/or related investigations.
• Lead the preparation for and execution of regulatory inspections.
• Approve deviations and investigations, including out-of-specification (OOS) investigations.
• Manage material disposition for commercial and clinical trial materials.
• Manage the review of product release and stability data.

Qualifications:

• Demonstrate proficiency in overseeing and managing CMO relationships.
• Comfortable with approximately 25% international travel to two sites.
• 5+ years of experience in Quality Assurance.
• Familiarity with cGMP standards.
• Possess a scientific degree (BS) and have at least 5-8+ years of experience in the pharmaceutical/biotech industry.
• Preferred experience with topical and liquid dosage forms.