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Director of Quality Assurance
Company : Bio Pharmaceutical
Location : Greater Boston Area
Status : Full Time, Employee
Job Description
The company is a leading pharmaceutical and ophthalmic product development and contract manufacturing company in the greater Boston area.
The Director of Quality Assurance will be the leader in establishing QA strategy, and for the implementation, execution and maintenance of Quality Assurance Systems. The Director will ensure all FDA and International regulations for Pharmaceutical manufacturing are met at this facility, including but not limited to NDA and IND submissions.
This position is responsible for the management, execution and coordination of QA activities, including QC Chemistry and QC Microbiology, that are required in order to meet all quality standards. This senior position will liaise with other staff throughout the organization to ensure that the QA system is functioning properly and coordinated with manufacturing. Where appropriate, the Director of QA will advise on systemic changes, and ensure that their implementation is successful by providing training, tools and techniques to enable others to achieve quality.
The Director of QA plans and directs work activities, and continuously monitors progress to ensure that responsibilities are clear, and that goals and objectives are accomplished efficiently, completely and on schedule. This person will ensure that work is performed in compliance with department SOPs and cGMPs.
The successful candidate will have strong leadership skills and be able to inspire team confidence and respect while motivating team members in a creative and effective manner. Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
BS in Chemistry/Biology or related field with 15 years Quality Assurance experience and 8 years at management position working in a CGMP regulated sterile fill-finish pharmaceutical manufacturing environment. Strong technical writing skills are highly preferred.
The company offers a competitive salary and excellent benefits including medical, dental, short-term disability, 401(K), 125 Cafeteria Plan, and tuition reimbursement.
Interested applicants should forward their resume to RCollins@GoldmanCollins.com
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