Director Quality Assurance


Job ID 19-00131

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

DESCRIPTION
- Reports – 4 direct, approx. 20-25 indirect
- Monitoring activities  within  QA Operations, Compliance  and  QA Documentation  Departments
- Walk-through of the facility and work with cross functional areas to assess QA support.
- Approval of Quality Documents and policies as applicable
- Attend management and/or issue resolution meetings as applicable
- Prepare Quality Review Metrics and Present to the Management as applicable
- Lead audits for the FDA and Clients. Prepare audit responses
- Attend Client meetings



Qualifications

QUALIFICATIONS
- Minimum 10 years of management experience in leading Quality/Quality Assurance in Pharmaceutical Industry.
- Must have – generic pharma exp; solid dosage, exp with all aspects of the ”train” – total mftg operations (packaging, dispensing, warehouse, etc), liquids a+.
- cGMP, DEA, FDA and regulatory knowledge. Exp with FDA, DEA, social audits.
Min of BA/BS.
- Good communication skills, written verbal, ee development, etc. Min 10 yrs exp.
- Preferred – someone with Chemist/Scientist background, degree
- Experience in leading regulatory and client inspections, preparation of responses and acting as a liaison between the regulatory agency and the company
- Experience working with cross-functional areas and corporate
- divisions Experience in handling Recalls and Field Alerts
- Experience with the DEA is preferable
- Hands on knowledge and experience with Pharmaceutical Manufacturing of Oral Solid Dosage form products.