Experienced Manager of Quality (RTP Pharma/External Manufacturing) – Top $$

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

Our client, a Raleigh area pharmaceutical firm with multiple products on the market and several launches planned, is actively recruiting for a highly skilled and knowledgeable Quality Manager to assume key role on its Quality Assurance team.

This company outsources all manufacturing, packaging and distribution functions.  Most suppliers are overseas, and this Quality Manager will drive all Quality efforts related to the External Manufacturing functions.  It is a critical role and Company will offer generous package to attract and retain the right candidate.

Key Things to Note:

  • The focus of this role is overseeing Quality for commercial products (APIs and FDPs) that are manufactured by 3rd party vendors.  Experience driving Quality for outsourced commercial product will be important.  Global experience and packaging experience are both preferred.
  • This Manager will be a key liaison with all manufacturing, packaging and distribution vendors.  Seek Quality Manager who has a history of developing productive while congenial relationships with these key vendors.
  • This is hands-on Management role that will require a roll-up-your-sleeves candidate who will balance strategic, high impact responsibilities with day-to-day tactical tasks.  We seek a doer.  This Manager will supervise one QA Specialist.
  • This is a growing company in which policies and practices are continually revised and enhanced to meeting changing demands.  Seek candidate who enjoys contributing to the “build.”
  • This is a hybrid role – splitting time with remote and on-site days.  COVID Vaccinations are required.

This position will involve providing day to day Quality input and oversight for successful life cycle development and commercialization of Company products and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements, and the company’s Quality Management System.

Selected Responsibilities:

  • Acting as key liaison for external manufacturing vendors; Ensuring clarity around expectations on specifications, timelines, communications, etc. and addressing questions in a timely manner such that expectations can be met.
  • Approving and releasing commercial product; Ensuring that all documentation for release is present, accurate and compliant.
  • Leading investigations associated with non-conformances and deficiencies; Ensuring that all incidents, complaints, and investigations are properly documented.
  • Verifying corrective actions for prevention of reoccurrence are completed as prescribed.
  • Reviewing and approving Quality records/documentation from third parties, including but not limited to product and process change controls. (e.g., master batch records, incidents and investigation reports).
  • Conducting formal risk assessments for CMOs and CPOs and ensuring implementation of identified controls/control plans.
  • Helping to ensure timely launch of new products by serving as the Quality lead for technical transfer activities at external manufacturing partners and supporting manufacturing activities.
  • Continually assessing applicability of Quality systems for managing CMO and CPO compliance and managing metrics for CMO and CPO Quality.

Targeted candidate will offer a related scientific degree and 7+ years of Quality-related experience within the pharmaceutical industry.  Substantial GMP compliance work related to external manufacturing and packaging vendors will be essential. 

Other priorities include:

  • Demonstrated knowledge global regulations (i.e. ICH guidance, FDA/EMA GMP regulations and etc.) for manufacturing, packaging, and distributing active pharmaceutical ingredients and finished drug products.
  • Experience evaluating quality systems specific to different manufacturing environments.
  • Demonstrated analytical skills to lead investigations of quality issues and justify CAPA with appropriate documentation.
  • Experience with assessing validation requirements for manufacturing processes, facilities, and equipment.
  • Record of longevity, impact and growth in previous roles

Finally, we seek a candidate with the demonstrated ability to develop strong collaborations with colleagues as well as key contacts at vendor partners.  The outsourced relationship works when there is mutual respect amongst the players.  We seek candidates who will foster the positive, productive relationships needed here.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.