Director of Biopharma Quality/ Regulatory Affairs U

Company Name:
Hess Associates
Our client is a well respected and financially sound Life Science company located in the midsouthern USA. This biopharmaceutical company is seeking a Director of both Regulatory Affairs as well as QC/QA for their manufacturing arm. The ideal candidate would have strong experience in biopharma or medical device quality assurance/ quality control/ regulatory affairs, able to develop programs that eliminate the production of defective product. The Director would also be adept at developing sound Quality Management Systems (QMS) to so that company complies with all federal and international standards.
Will relocate from USA or Canada.
- Serve as prime contact with all regulatory bodies worldwide including the FDA, and all outside auditors, keeping up to date.
- Run audit processes for quality production internally and for FDA requirements.
- Knowledgeable re and ensure compliance with all FDA and all ISO and cGMP standards (13485, 9001), (21CFR).
- Work with QA QC Regulatory counterparts in other company facilities,
- Handle all processes involved in setting up and maintaining a Quality system.
- Apprise senior executives of all QA issues related to present and in pipeline products.
- Help establish all Policies & Procedures with respect to QC/ QA/ Regulatory Affairs.
- Complaint handling, technical problems and solutions, budgetary and expense matters.
- Assure raw material quality.
- Enact a CAPA program as required to ensure quality at all times, and do quality training.
- Middle management and individual unit responsibility.
- Hiring firing full cycle responsibility, including training, performance reviews.
BS/ MS Life Sciences/ Biology/related.
At least 10 years' QC, QA and Regulatory Affairs experience.
Min 5 years' as senior management.
Background in Biopharmaceuticals or Medical Device Industry.
Experience playing lead role in customer and internal quality audits, and FDA audits as well.
Master Control Documentation System
Able to read industry publications, financial and legal documents.
Background interacting with clients, dealing with complaints, working with regulatory bodies.
Strong English communication, presentation, troubleshooting skills.
Summary: Strong biologics background, Regulatory, validations, and QA/QC.
Will relocate from USA or Canada.

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