GMP Operational Quality Senior Specialist

Job Description

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.