Director, GMP QA

2 weeks ago

South San Francisco, United States Meet Full time

Title: Director, GMP QA

Company Overview: our client is a dynamic and innovative small molecule biotech company committed to advancing novel therapeutics to address unmet medical needs. With a focus on cutting-edge research and development, they are dedicated to bringing transformative treatments to patients worldwide. We are partnered to recruit an experienced Director of GMP QA to join their team and contribute to their mission of improving patient outcomes.

Position Overview: As the Director of GMP QA, you will play a critical role in ensuring compliance with Good Manufacturing Practice (GMP) regulations and standards to maintain the quality and integrity of products throughout the manufacturing process. You will lead a team responsible for overseeing quality assurance activities related to GMP manufacturing operations, including manufacturing, testing, packaging, labeling, and distribution.

Responsibilities:

-Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with GMP regulations and standards.

-Provide leadership and guidance to the GMP QA team, fostering a culture of quality and continuous improvement.

-Collaborate with cross-functional teams, including manufacturing, quality control, regulatory affairs, and supply chain, to ensure alignment and consistency in quality processes.

-Review and approve GMP documentation, including batch records, validation protocols, deviations, and change controls, to ensure compliance with regulatory requirements.

-Conduct internal audits and oversee external audits by regulatory agencies and third-party partners, ensuring timely resolution of findings and implementation of corrective actions.

-Lead investigations into quality events, deviations, and non-conformances, identifying root causes and implementing corrective and preventive actions (CAPAs) to prevent recurrence.

-Stay current with evolving regulatory requirements and industry best practices related to GMP manufacturing, providing guidance and training to internal stakeholders as needed.

-Serve as the primary point of contact for GMP QA-related inquiries from regulatory agencies, customers, and partners, ensuring timely and accurate responses.

-Drive a culture of quality and compliance throughout the organization, promoting awareness and understanding of GMP requirements and principles.

Qualifications:

-Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.

-Minimum of 6 years of experience in quality assurance within the pharmaceutical or biotech industry, with a focus on small molecule GMP manufacturing.

-Extensive knowledge of FDA and international GMP regulations and guidelines.

-Strong leadership and management skills, with experience leading and developing high-performing teams.

-Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional areas and influence stakeholders at all levels of the organization.

-Proven track record of managing GMP QA activities in a fast-paced, dynamic environment, with the ability to prioritize and manage multiple projects simultaneously.

-Experience with regulatory inspections and audits, including preparation, hosting, and response management.

-Detail-oriented mindset with a focus on continuous improvement and driving excellence in quality and compliance.

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