Director of Quality

Responsible for ensuring corporate compliance with the FDA, the Director of Quality assists in formulating of company policies and the development of long-range quality system goals and objectives. This executive will:

Oversee Quality management system that complies with the Food and Drug Administration.

Manage Document control, quality control, internal quality auditing, complaint handling, customer audits, supplier programs, product release and other quality system activities.

* Maintain ISO 13485 requirements
* Ensure cGMP
* Communicate customer requirements
* Stay informed of the latest regulatory requirements
* Review and scrutinize compliance
* Implement appropriate corrective and preventive actions
* Present performance reports to C suite
* Continuously improve quality systems
* Participate in NPI
* Manage Staff

Required skill set:

1. BS required, Masters level preferred.
2. Significant FDA quality control methods and quality assurance system experience
3. 10+ years experience in the medical device, biotech or pharmaceutical industry (biotech/biologics strongly preferred)
4. Must have at least 5 years quality management in an FDA environment
5. Excellent knowledge of cGMP, ISO 13485 and quality system requirements
6. Track record of managing and developing people

Compensation: mid to hi 6 figures

Location: Wareham / Cape Cod, MA

Relocation: available

Contact: Leslie Gabriele
Gabriele & Company
Recruiters for Manufacturing and Materials
781-276-7999