GMP Operational Quality Senior Specialist

GMP Operational Quality Senior Specialist

Contract Type:

Contractor

Location:

Boston

Industry:

Pharmaceuticals

Contact Name:

Flora Pollack

Contact Phone:

Date Published:

02-Sep-2025

GMP Operational Quality Senior Specialist

Boston, MA (Onsite 3x per week)

Schedule: Standard Office Hours

Duration: 24-Month Contract

Pay Range:$65-70/hr



Our client is a global biopharmaceutical leader dedicated to developing innovative therapies. This position provides an opportunity to play a key role in supporting quality and compliance activities across multiple programs in a collaborative, fast-paced environment.



Key Responsibilities

  • Provide quality oversight for root-cause analysis and product impact assessments related to deviations, OOS, and OOT investigations, ensuring appropriate CAPA actions are implemented.
  • Support change control assessments, implementation, and closure.
  • Draft and revise Quality Agreements with external partners and suppliers.
  • Represent Quality on cross-functional teams, applying strong communication and collaboration skills.
  • Review executed batch documentation and testing data to support disposition of drug substance, intermediates, and finished products.
  • Ensure compliance through GMP document review, including certificates of analysis and specifications.
  • Contribute to continuous improvement projects and compliance optimization across functions.

Preferred Qualifications

  • Experience supporting multiple projects and cross-functional teams within defined objectives and timelines.
  • Strong written and verbal communication skills, with ability to present complex information effectively.
  • Ability to collaborate across groups, departments, and project teams.
  • Demonstrated capability to evaluate quality matters and solve problems using precedent and technical judgment.
  • Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
  • Proficiency in Root Cause Analysis (RCA), CAPA, and event investigations.
  • Operational QA experience in analytical or manufacturing settings (small molecule preferred; biologics, devices, and gene therapy experience a plus).
  • Practical GxP knowledge across the product lifecycle, including:
    • GMP regulations and application to manufacturing
    • Root Cause Analysis methodologies and tools
    • Analytical techniques and data review
  • Strong decision-making skills using risk-based approaches.
  • Effective communication across diverse audiences with strong relationship management skills.

Required Qualifications

  • Bachelor’s degree in a scientific or allied health field (or equivalent).
  • 2 years of relevant work experience, or an equivalent combination of education and experience.

...

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