Director, Quality Assurance EpiCept Corporation - Tarrytown, New York (Greater New York City Area) Job Description This position is responsible for all Quality Assurance related matters for the development and commercialization of drug products at EpiCept. EpiCept currently has no in-house R & D Labs or manufacturing infrastructure. The incumbent will work with contract sites (e.g., QA/QC/Manufacturing departments etc.) of EpiCept's contract development, clinical and manufacturing sites (North America and Europe) and will be responsible for all quality and compliance with regulatory (FDA, EMEA etc.) requirements (GLP/GMP/GCP standards) for EpiCept's products at these sites.
This position reports to the Sr. Vice President, Pharmaceutical Development Desired Skills & Experience Responsibilities:
-Set the standards for Quality and compliance within the Company -Develop and implement SOPs as needed. Supervise the continuing evolution of the Company's QA systems. -Ensure that contract manufacturing sites (API, Drug Product, commercial packaging, Clinical labeling/packaging etc.) conform to FDA/EMEA regulations (cGMPs, GCPs etc.) and produce product of the highest pharmaceutical quality. -Conduct qualifying and periodic follow-up audits of the contract sites to confirm regulatory and Quality compliance and document findings and corrective action if required. -Lead in the development of good follow-up programs and monitor actions of contractors and vendors to ensure they complete any necessary corrective actions identified in audits. -Responsible to review and approve all Master Batch Records and Specifications. Review completed batch records for API, Drug Product and release API, drug product for use (clinical and commercial). -Review and approve change controls for API and drug product manufacturing processes and procedures, analytical procedures, and related batch records/testing, SOP's; assure appropriate reports are issued, approved and implemented. -Develop validation protocols for new, or changes to existing, manufacturing and testing procedures -Assemble and submit relevant QA information and data to the Regulatory Affairs Dept as needed. -Manage and conduct special investigations / projects as required.
REQUIREMENTS: -Must have a minimum of 7 years small molecule Rx Quality Assurance experience in the Pharmaceutical Industry. Ideally this candidate will have 10-15 years total industry experience. -Must have 5+ years direct accountability for leading QA efforts in a pharmaceutical / biotechnology company -Demonstrated and current knowledge of GLP/GCP/GMP regulations and FDA and EMEA requirements. -Must have experience managing contract service providers (including CMOs) -Expert level understanding of small molecule drug development (sterile and non-sterile), clinical study support, and knowledge of regulatory (FDA and EMEA) requirements. -Ideal candidate will be team oriented, a self-starter and have experience with injectable (preferably oncology) products with strong analytical chemistry knowledge. Familiar with compliance management and software. -Must have a BS or MS in pharmacy, science, or medically related field. Demonstrated track record of success working on multiple small molecule product development projects and commercial Rx products. -Effective communication and presentation skills -Comfortable around executive management -Excellent project management, technical writing and data/document review skills.
Additional Information Posted:September 14, 2011 Type:Full-time Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Compensation:salary is commensurate with experience Referral Bonus:None Job ID:1972243