Kelly Scientific Resources is seeking a QA Manager/Director for a modern, client-driven, contract analytical, formulations, and development-support laboratory serving the pharmaceutical, biotechnology, and associated diagnostics industries.Our client specializes in analytical and biological testing in support of product characterization, lot release, and stability programs required for pharmaceutical and biopharmaceutical development. This position will oversee the Quality Assurance function and have responsibility for developing, implementing, and supervising all QA programs and activities. Responsibilities will include further developing and maintaining all internal cGMP policies and procedures, and assuring comprehensive compliance with those policies and procedures. Specifically, the responsibilities will include, but are not limited to, the following:-Advancing, evolving, and improving all laboratory quality systems-Ensuring compliance of operational staff to cGMP regulations-Maintaining all quality documentation and document tracking systems-Conducting and coordinating internal and external audits/inspections-Communicating/interacting with clients, regulatory authorities, auditors, etc.-Reviewing/approving cGMP protocols and reports including those in support of lot-release programs, stability, qualification, and ICH validation activities-Investigating, documenting, and tracking cGMP deviations, change controls, OOS, CAPAs, etc.-Providing guidance and training to employees to ensure compliance to cGMP's and SOP'sExperience:Bachelor's degree in chemistry/biochemistry or in a life science plus 5-10 years quality assurance leadership experience in biotech or pharmaceutical industries. In-depth experience in FDA and EMEA compliance/quality issues. Strong leadership skills as well as good management, communication, writing and presentation skills, computer skills, energy and professionalism are also critically important.QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!Kelly Scientific Resources®(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.