Responsibilities of the Quality Manager:
- Provide leadership and oversight to QMS groups to ensure that projects are completed in a timely and effective manner.
- Participate in building/improving and maintaining quality systems that are compliant with all applicable regulations and standards moving from clinical to commercial development.
- Create, implement and maintain SOPs, policies and procedures consistent with corporate and quality objectives.
- Perform routine reviews on manufacturing batch records and the associated analytical data and documents in support of product disposition in accordance with specifications and SOPs.
- Perform method, process, equipment, and cleaning qualification/ validation documentation review/approval.
- Other tasks as assigned by Departmental Management.
Requirements of the Quality Manager:
- BA/BS in life science or engineering related discipline with 2+ years QA experience in a biotech, pharmaceutical, or medical device environment.
- Experience working with Quality Management Systems.
- Familiarity with FDA or cGMP guidelines.
- Proficient in Microsoft word and other QMS related software.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.