GMP QA Consultant (Director)

Job Summary:

The GMP QA contractor will oversee and lead strategy and execution of the companies GMP Quality activities. The individual will oversee CMO QA activities with a focus on ensuring compliant application of US and EU GMPs. The individual will be a QA subject matter expert supporting CMC activities including tech transfer, manufacture, and release of product, change management, audit of contract manufacturers/contract testing labs. Partnering seamlessly across the companies' functions, the individual will implement and monitor quality objectives critical to programs, aligning with expected deliverables, metrics, and company goals.

Essential Responsibilities:

• Proactively provide GMP compliance leadership
• Oversee CMO QA activities, ensuring consistent application of relevant cGMPs and other relevant regulations and guidance
• Review and approve documents as required, including protocols, reports, document changes, master batch records, specifications, test methods, OOS investigations and deviations, etc.
• Lead and conduct product quality oversight, including product batch record review and product release
• Work dynamically and proactively with Quality Assurance and Functional Area leads to facilitate development of GMP-compliant procedures
• Review and approve investigations, providing assurance of complete and accurate documentation
• Execute GMP audits of key suppliers, contract manufacturers, contract testing laboratories, and manufacturers, as required
• Establish Quality/Technical Agreements with suppliers, contract manufacturers and testing labs, as required
• Lead in the execution of Risk Assessments and oversight of Design Controls associated with combination product/medical device requirements
• Identify and escalate serious compliance issues to the Head of Quality

Experience and Qualifications:

• Expert understanding of GMP and quality management requirements, including ICH Q8, Q9, and Q10, US CFRs and EU GMPs
• Expert in Tech Transfer, scale up, and commercial Drug Substance / Drug Product manufacturing
• Experience with combination products and medical device regulations preferred
• Bachelor's degree required, with 15 + years relevant GMP experience
• Remote role, travel required for audits as necessary
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.