FierceBiotech and FiercePharma Jobs
Senior Director/AVP Quality Assurance - Advantage ONE Executive Search
Aug 08
Location: Central, NJCategories: Administrative
Position Description
Our client is an exceptional company with oncology products on the market worldwide, and have a robust pipeline of potential products. Their future is very bright. They are the perfect size, small enough to provide excellent visibility and a real opportunity to impact the future success of the company, BUT large enough to provide solid support and reasonable security. Now is the time to explore new career horizons. Direct the activities of the quality assurance compliance and change management departments. Interact with critical Biotech commercial and clinical API and Fill Finish manufacturing operations, facilities and Quality Control labs to ensure a successful compliance profile. Partner with senior management and critical contract manufacturers to resolve compliance issues. Ensure regulatory observations associated with products are adequately addressed and completed on schedule. Provide guidance to assist co-workers with trouble-shooting investigations and problem resolution. Implement quality improvement plans with management. Ensure regulatory compliance and procedural consistency between manufacturing facilities for regulatory inspectors. Interact with the FDA and other regulatory agencies. Prepare and oversee department budget.
Responsibilities: 1. Direct the QA Compliance and change management departments to ensure cGMP compliance of manufacturing operations, facilities and Quality Control labs. Provide GLP compliance oversight to the Toxicology labs. 2. Keep Senior Management informed of compliance status. 3. Manage staff and provide critical oversight for investigations, compliance status, and problem resolution. 4. Interface with FDA and other regulatory agencies during inspection of critical contract manufacturers. Plan and conduct Regulatory inspection readiness activities. 5. Provide oversight for non-conformance events ensuring timely and thorough investigations. 6. Review/approve non-conformance events, change controls, procedures, protocols, reports, etc. as needed. 7. Utilize metrics and other tools to monitor the state of compliance and implement continuous improvements accordingly. 8. Plan and administer the department budget. Monitor department spending to remain on track with budget.
Requirements: 1. BA/BS degree in the sciences, advanced degree preferred with a minimum of 15 years experience in the biopharma industry with at least 10 of those years in Quality Assurance. Previous technical experience should be in biotech manufacturing processes (e.g. large scale cell culture, purification). Prior lab experience preferred. Fill Finish a plus. 2. Minimum of 5 years management experience. 3. Must possess thorough knowledge of GMPs, and current FDA and other regulatory authority policies for pharmaceutical and and/or biotech products. Knowledge of GLPs a plus. 4. Have a conceptual understanding of all related business areas. 5. Must be assertive, lead by example, and build collaborative relationships. 6. Strong analytical, problem solving and communication skills essential.
