Director of Quality Assurance – Southeast

The Director of Quality Assurance will develop and deploy the quality system for manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company policies and procedures. The incumbent will manage the Quality Organization in support of business and Company initiatives.  The successful candidate will interface with Production, Regulatory Affairs, Marketing, New Product Development and other departments to maintain awareness of Quality activities.  The incumbent will understand and deploy processes to assure conformance to government regulations, industry standards and Company policies. The incumbent will manage the team for regulatory inspections and will assess and advise Executive Leadership on quality decisions. The incumbent will manage interactions with vendors, suppliers and FDA inspectors concerning the quality of products, systems and processes.  The incumbent will identify and manage continuous improvement projects that may span multiple sections or departments with the goal of achieving quality, reliability and cost improvements. The incumbent will manage quality compliance for Contract Manufacturers, will manage GMP and job-specific training program, will manage internal and external auditing, develop a corrective action program to ensure the appropriate responses to deviation or audit deficiencies, review and approve SOP’s, handle production process monitoring, protocol review and batch  record documentation and approval.

Qualifications include B.S. in science or engineering, advanced degree preferred, 10+ years of Quality Assurance in the pharmaceutical products or supplement industry with 7 years of management experience., strong knowledge of FDA government regulatory requirements pertaining to manufacturing of pharmaceutical products or supplements, strong leadership skills and success managing a team, strong analytical and problem solving skills, success working with multifunctional, global teams, excellent interpersonal, communication, negotiation skills, and a high level of human relations skills in selecting, developing and motivating people. Excellent motivational and cross-functional team building skills are required.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Product Development Manager – Northeast

The incumbent will develop the overall CMC document strategy with Regulatory and CMC leaders and then execute document creation, collation, editing and review. The incumbent will work within a team to ensure consistency, accuracy and flow of message  that Regulatory will submit to FDA-CVM to support new ANADAs, and supplements and amendments to existing applications.

Qualifications include a degree in life sciences combined with experience in CMC technical writing (preparation of CMC/regulatory documentation). The successful candidate will have 5+ years of product development and manufacturing experience in the pharmaceutical industry. Computer literacy is required.  

For immediate consideration,  please Apply Now.