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Job #03568

About our client Our client is a rapidly growing specialty pharmaceutical company that is focused on the development and commercialization of women’s health and gastroenterology products. The company has an experienced management team and excellent revenue momentum. This is a unique opportunity for someone that wants to put their drive and to work for an entrepreneurial organization that rewards initiative. Position Location Senior Manager of Quality Assurance Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop the company’s Quality Assurance Program in collaboration with partners/colleagues 2) Ensure company’s drug product/clinical trials supplies production is carried out as per corporate and statutory regulations 3) Implement and manage the GMP Quality System in collaboration with Development, QA and Corporate Business strategy 4) Direct the internal and external GMP Audit Program to support business and regulatory requirements 5) Ensure new CMOs are assessed for GMP compliance and certified prior to supply of services and or goods 6) Develop and implement a system to manage change control, OOSs, deviations and product complaints 7) Ensure approved API and excipient supplier program is established and managed as per company and regulatory standards 8) Approve batch manufacturing records and analytical methods 9) Authorize release of commercial and clinical trial supplies 10) Develop and manage a system that ensures that the company’s documentation is complete, monitored, accurate and current 11) Include specifications, validation protocols, test scripts/reports, analytical methods, formulation reports, stability protocols/reports, labeling, technical and clinical study reports, etc. in documentation 12) Ensure appropriate standards are applied to support R&D IT, cleaning, equipment and method validation activities 13) Host and coordinate all aspects of FDA (and other) inspections/audits 14) Lead and manage a productive and respected QA Team 15) Support technical training initiatives 16) Contribute towards building a quality mindset throughout the organization Requirements 1) BS in a scientific field (Advanced degree and/or Quality certification preferred) 2) Minimum 5+ years of experience in managing QA of CMOs for a pharmaceutical company 3) 10+ years of experience in pharmaceutical QA (GMP focus) including significant time in a leadership role 4) Proven experience in leading regulatory inspections including hosting, follow up and close-out 5) Experience in Rx/OTC dosage forms including topical, solid oral, liquids and sterile injectables and dietary supplements 6) Experience in leading FDA audits of GMP compliant facilities 7) Impressive track record of developing and implementing policy and procedures in response to growth 8) Extensive background in using third party vendors and CMOs 9) Demonstrated success in a similar role in an evolving, highly-collaborative setting 10) Deep and broad knowledge of quality regulations and practices