GMP Quality Assurance Manager (Combo/Device Products) – RTP, NC Pharma

Job Type: 
Other Life Science Positions
Quality Assurance and Quality Control
Life Sciences
Employment Category: 
Direct Hire

Our client, a growing biopharma in the RTP area, is actively recruiting for a highly skilled and knowledgeable Quality Assurance Manager to oversee Quality efforts for its combination/drug delivery products. 

This is an essential and impactful role overseeing Quality for  both development and commercial products.  The QA Manager will provide direct oversight of all GMP related activities at the internal RTP facility and the CMO facilities. Company will pay industry-leading wage to attract and retain the right candidate.

Key Things to Note:

  • This Quality Assurance Manager will supervise a small team as well as oversee the work of numerous vendor partners.  Seek a seasoned supervisor/leader of people and cross-functional teams
  • These are combination products.  QA work related to API, finished drug product, component, and drug delivery systems / medical device will be important.
  • This company works with suppliers across the globe.  Seek candidate with familiarity with global QA practices and is accustomed to managing Quality in an outsourced setting.
  • This is an emerging business in which policies and practices are being enhanced and developed to meet the needs of the future.  Seek candidate who brings the knowledge, ingenuity and initiative to contribute to its build.
  • This is a hybrid role involving 2-3 days onsite at the Durham site.  This is not a remote position.
  • Travel is estimated up to 20%.

Selected Duties:

  • Develop, implement, deploy, and maintain adequate and compliant quality systems, procedures and processes supporting commercial and development products at the RTP site and at partners globally
  • Oversee and manage the day-to-day execution of QA operations supporting GMP manufacturing and laboratory testing activities for both commercial and development drug device combo products, internally and at contract facilities globally. 
  • Partner with Science and Technology teams for Drug product and Device Manufacturing to support development to commercial medical device/drug products
  • Manage the Global Supplier Management Program, to include 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
  • Support the Product Quality Complaint (PQC) program - ensuring complaints are received, inspected, summarized and recorded
  • Work with QA groups at contract manufacturing (CMO) and test (CTL) facilities (both domestic and international) to ensure API, drug product and delivery systems are manufactured and tested in accordance with established procedures and all deviations, non-conformances, and laboratory investigations are properly documented and resolved
  • Act as Quality Representative and primary reviewer on design and development projects
  • Review and assure the quality of documents, to include: Design History Files, 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.
  • Review and release executed GMP manufacturing batch records for compliance to manufacturing processes
  • Review CMC and other documents in preparation for Regulatory submissions
  • Support regulatory inspections as the process owner for API and drug product and drug product delivery systems release and supplier management.

Targeted candidate will offer a related BS and 8+ years of Quality Assurance experience in the medical device / drug device combo space, to include 3+ years of experience overseeing outsourced manufacturing and laboratory partners

Other requirements include:

  • Expertise in QA and Compliance for medical device or drug device combo products
  • A strong understanding of global CGMP and compliance requirements for the manufacturing of API and sterile filled, finished drug product, sterile combination or device products
  • In-depth knowledge of 21 CFR P Part 4, Part 11, Parts 210/211, Part 820
  • Expertise in quality systems, validation principles, and engineering design fundamentals
  • Experience assuring quality over Design History Files
  • Supervision/team lead experience
  • Longevity and growth in previous roles

Finally, this is an emerging environment and employees are hands-on, flexible and mission-driven.  We seek a candidate whose Quality credentials are complemented by the versatility, resourcefulness and commitment to thrive in this dynamic Pharma setting. 

Please forward Word resume for prompt consideration.  Local candidates targeted.

Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond).  We specialize in Office Support, Life Science and other Professional Services positions.  To view our current openings, please visit our website at  www.frankelstaffing.com