Manager - QA / Systems

Description Covance is expanding its biotechnology services business to the United States. This is an exciting opportunity to get in on the ground floor of a rapidly growing scientific service offering with one of the world’s premier drug development companies. The biotechnology business unit will provide a comprehensive portfolio of contract GLP and GMP laboratory services supporting the development and manufacture of biotechnology, biopharmaceutical and vaccine products. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

It is a great time to join Covance!

We are currently seeking a Manager - QA Systems for our biotechnology lab in Greenfield IN.

As the manager you will:

- Manage the oversight of Quality Systems and supporting services.
- Manage compliance review, regulatory inspections, GMP documentation, and electronic Quality Management systems of the Biopharmaceutical lab.
- Provide management direction to the Quality Systems team.
- Assist in the planning and managing of business development and marketing activities for section to form client/Company partnerships.
- Define the startup priorities, systems and SOPs for a newly defined business unit
- Meet with clients on site and at their sites as necessary to support their needs and determine the appropriate resolution of client issues.
- Guide direct reports, internal clients and less experienced peers in GLP and cGMP interpretation.
- Write SOPs supporting Quality systems, data systems, technical issues and instrumentation

Experience:

- Experience with GMP compliance in the biotechnology, biopharmaceutical or related contract testing industry required.
- Experience with compliance review, regulatory inspections, GMP documentation, and electronic Quality Management systems desired
- Expertise in the design, implementation and interpretation of Quality Systems supporting all aspects of the development, manufacture and license of Pharmaceutical products
- LIMS, VelQuest or Documentation experience preferred.
- Strong written and verbal communication skills are needed.
- Experience with regulatory inspections and startup operations are desirable.
- Experience in the interpretation of analytical data
- Functional knowledge of LIMS and other electronic data systems
- Strong knowledge of GMP and GLP requirements At Covance, you can make a difference, not only by helping to deliver life-saving and life-enhancing medicines to people around the world, but also by helping us become a great company. We are committed to delighting our clients with the broadest and best service portfolio in our industry. This ever-changing environment energizes our people and offers exceptional growth opportunities.

Education:

- Bachelor of Science/Arts (BS/BA) degree in Quality Systems or related degree.
- 5-10 years of experience in the biotechnology, biopharmaceutical, pharmaceutical or supporting industries - 3-5 years of experience in a Quality Assurance role in a GMP regulated portion of the Biotechnology, Biopharmaceutical or supporting industries.
- 3 or more years of supervisory and/or managerial experience
- Expert knowledge of GMP compliant Quality systems pertaining to Biologics

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.