GMP Operational Quality Senior Specialist (v496)

  • Contract Duration: 6+ months, possibility to extend, Hybrid Remote
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search


Lenox Executive Search is looking for a GMP Operational Quality Senior Specialist for a contractual role with one of our global pharmaceutical clients. Pharmaceutical manufacturing quality assurance experience is a MUST!!!

General Summary of a GMP Operational Quality Senior Specialist:

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives.

Key Duties and Responsibilities of a GMP Operational Quality Senior Specialist:

  • Supports authoring of Annual product reviews ensuring appropriate CAPA actions are identified.
  • Assists with preparation of Quality Management Review materials
  • Supports regulatory surveillance activities
  • Identifies and facilitates continuous improvement efforts
  • Helps represent Company Quality on cross-functional working teams, applying strong communication and collaboration skills.
  • Support continuous improvement projects
  • Annual Product Review
  • Trending product quality events, trends of analytical events

Knowledge and Skills of a GMP Operational Quality Senior Specialist:

  • Experience supporting multiple projects/teams within stated objectives and timelines
  • Experience supporting cross-functional team members and collaborating effectively
  • Good communication skills (written and verbal) and the ability to exchange potentially complex information
  • Able to integrate activities with other groups, departments and project teams as needed
  • Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
  • Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
  • Expanded conceptual knowledge of cGMP’s in a pharmaceutical setting
  • Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Technical Writing

Education and Experience of a GMP Operational Quality Senior Specialist:

  • Bachelor’s degree in scientific or allied health field (or equivalent degree)
  • 5-7 years of experience, or the equivalent combination of education and experience
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