Director of Quality Assurance

We currently seek a Director of Quality Assurance to work at a leading BioManufacturing plant in the Midwest. The candidate will provide expertise regarding federal, state, and local regulatory guidelines including FDA, cGMP/21CFR, ICH guidelines, GLP, and a working knowledge of OSHA/29CFR and EPA/40CFR guidelines. Candidates for this position will have a solid scientific background with proficiency in Quality Management (QA/QC). Knowledge of GAP and APHS permitting procedures would be a plus. The candidate must also possess strong communication, interpersonal, and writing skills, and must be able to work in a team environment.

Responsibilities include:
- Implement quality systems
- Monitor a controlled manufacturing facility
- Establish guidelines for research and pre-clinical manufacturing activities
- Represent the quality function in the design review for new or modified facilities, equipment, and processes
- Provide quality overview in support of validation activities
- Implement and monitor a cGMP training program, and document control system
- Interface with the FDA (CDER) and other applicable regulatory authorities
- Work with clients and prospect companies' quality units as appropriate

Position Qualifications include:
- BS degree in life sciences, advanced degree preferred
- 10+ years of quality experience in the biopharmaceutical industry
- 7+ supervisory experience
- Start-up operation and facility design experience key
- Formal training in GLP/cGMP and Quality Assurance
- Travel required

Interested candidates please email your resumes to: career@searchmastersinternational.com

These projects are used to represent job opportunities with Search Masters International. All positions may not be immediately available at this time.