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Quality Assurance Manager (Science & Biotech)
Durham, NC 27703
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Feb 02, 2022
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Job Description

Our client, a mid-sized pharmaceutical company and great team, is currently hiring!

Overall Purpose:
The QA manager is a critical member of the RTP Quality management team and provides QA support and ongoing direct oversight of all GMP related activities the RTP and CMO facilities. The role is a key contact point and quality representative which provides Quality Assurance (QA) support and oversight for critical API, finished drug product, and medical device delivery system. Oversees manufacturing/testing operations at contract facilities globally for development and commercial products. The role ensures that all quality-related issues are effectively communicated and managed between management and the contract manufacturers and laboratories.

Essential Duties & Responsibilities:
Primary Responsibilities
• Develop, implement, deploy, and maintain adequate and compliant quality systems, procedures and processes which support the commercial and development products and business objectives of the company and at the RTP site specifically.
• Oversees and manages the day-to-day execution of QA operations which support GMP manufacturing and laboratory testing activities occurring at the RTP facility. Partners with Science and Technology teams for Drug product and Device Manufacturing to support development to commercial medical device/drug products.
• Manages the Global Supplier Management Program and associated procedures and processes; including maintaining audit schedules and approved supplier lists; tracking, reviewing, and responding to supplier out-of-specification results, failure investigations, deviations, and change controls (equipment and document); participating in supplier audits; develops and deploys metrics and provides periodic updates on the Supplier Management program to site and executive management.
• Supports the Product Quality Complaint (PQC) program; ensuring returned complaint units are received, inspected based on specific complaint type and provide inspection summary into the respective complaint record. Additionally, ensures complaints are investigated and closed in a timely manner and supports the operation of the product quality complaint procedures and systems as required.
• Works directly with QA groups at contract manufacturing (CMO) and test (CTL) facilities (both domestic and international) to ensure the company's API and drug product including drug product delivery system and components are manufactured and tested in accordance with established procedures and all deviations, non-conformances, and laboratory investigations are properly documented and resolved in a timely manner.
• Review and approval of quality-related documents affecting products, including but not limited to: protocols/reports; qualification, validation, process and analytical method transfers and stability protocols and reports; analytical and qualification test results, including raw data; change controls, deviations, and laboratory investigations.
• Represents QA on various development, manufacturing, and continuous improvement project teams. Applies a phase appropriate GxP approach to quality and compliance when working with internal groups (Science and Technology, Manufacturing, Chemistry, Analytical, Regulatory, Clinical) during development to commercial activities to ensure both compliance and project timelines are maintained.
• Reviews and release executed GMP manufacturing batch records for compliance to manufacturing processes/steps, ensuring that all applicable documents, records, and forms are completed and attached.
• Development of controlled documents and procedures pertinent to QA activities and functions, as well as other procedures as deemed necessary.

Other Responsibilities
• Review CMC and other documents in preparation for Regulatory submissions, including IND, NDA, and Annual reports.
• Support the development, implementation, and maintenance of quality systems including, but not limited to: Supplier Management, Qualification/Validation, Distribution, Investigational product labelling and packaging, and Combination product requirements.
• Supports regulatory inspections as the process owner for API and drug product and drug product delivery systems release and supplier management.
• Conducts GMP training and supports the execution of training across the RTP site.
• Act as back-up to Director, Quality during regulatory inspections.