GMP QA Manager - vendor compliance at Plymouth

Job Description

Title: GMP QA Manager - vendor compliance

An industry leading, privately held pharmaceutical company is hiring.  We are a small molecule pharmaceutical company focused on making drugs that make a difference for patients.  Products include branded and generic prescription and over-the-counter medications focused on cardiology, dermatology, womens health, and diseases of the central nervous system.

Location: Plymouth, Minnesota

We are offering: competitive salaries, cash bonus among other excellent benefits to the pharmaceutical Quality Assurance manager who can manage vendor compliance of third-party suppliers.  If you are looking for a strategic leadership role where you can remain hands on in managing vendor compliance keep reading!

• The Manager, Vendor Quality, is responsible for providing leadership and direction to the development, implementation, and continuous improvement of the Vendor Quality Program. This role will oversee Vendor Evaluation by establishing quality assurance protocols & on-going monitoring criteria commensurate with material risk and finished product impact. The QA Manager will manage the interaction with third party contractors to facilitate existing Quality Agreements, Audit external suppliersand contractors to ensure compliance to appropriate FDA regulations. This individual will provide Quality support for current projects and new product development teams.
• This individual will manage a small team of QA specialists and auditors and oversee the vendor compliance systems.

Job Requirements

• Candidates must have a Bachelor’s degree, preferably in a technical field (e.g., Chemistry, Biology, Chemical Engineering) and 8 + years experience in quality auditing and vendor quality management preferably in the pharmaceutical industry. Broad working knowledge of Vendor Quality Systems and regulatory compliance programs required. 
• Candidates must have a minimum of 3+ years of supervisory experience required.

Core Competencies:
FDA, regulatory compliance, QA, Quality Assurance, pharmaceutical, vendor compliance, third-party QA, CMO, contract manufacturing, raw materials, audits, inspections, quality systems, external manufacturing compliance


Country: USA, State: Minnesota, City: Plymouth, Company: MR - Klein Hersh International.