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Senior Manager Quality Operations and Systems

Senior Manager Quality Operations and Systems

Thermo FisherPlainville, MA, US
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Senior Manager For Quality

We are in search of a forward-thinking Senior Manager for Quality to lead all aspects of the Quality Operations and Quality Systems at our facility. This is a pivotal leadership role for someone passionate about quality, team development, and innovation in advanced therapies. You'll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standardswhile shaping the future of our Quality organization.

Key Responsibilities :

  • Guide and empower a team of professionals specializing in Quality Operations and Systems, assisting with GMP manufacturing and warehouse operations
  • Ensure inspection readiness and regulatory compliance across all site quality systems
  • Lead all aspects of Supply Chain Quality, including supplier management, change notifications, and corrective actions
  • Develop a culture of quality by directing teams through policies, procedures, and guidelines
  • Establish culture of real-time quality oversight for manufacturing floor events and documentation review
  • Track and report key performance indicators to assess quality system effectiveness
  • Represent the site during regulatory inspections, corporate audits, and client visits
  • Drive risk management initiatives, including risk register updates and mitigation strategies
  • Collaborate cross-functionally on continuous improvement projects to elevate site performance and customer satisfaction
  • Serve as a strategic partner to clients, addressing quality-related inquiries and aligning product control strategies

Qualifications :

  • Bachelor's degree in a scientific or technical field required
  • 10+ years in Quality Assurance or leadership roles within biologics, pharmaceuticals, or cell / gene therapy
  • Strong knowledge of 21 CFR, ICH Q9 / Q10, ISO-14644, GAMP5, ASTM-E2500, and EU regulations
  • Proven success managing regulatory inspections (FDA, EMA, Health Canada)
  • Hands-on experience with audits, deviation investigations, and GMP batch record review
  • Demonstrated ability to build and lead hard-working teams
  • Knowledge, Skills, Abilities :

  • Deep understanding of GMP regulations and global quality standards
  • Strategic problem solver with a practical approach to complex quality challenges
  • Excellent communication and presentation skills
  • Strong organizational and prioritization capabilities
  • Skilled in technical writing and analytical problem-solving
  • Collaborative leadership style with a focus on continuous improvement
  • Physical Requirements :

  • Ability to gown for cleanroom environments
  • Capacity to read and review documentation for extended periods
  • Must be able to talk, hear, sit, and stand for long durations
  • Occasionally required to lift, walk, reach, stoop, kneel, or crouch
  • What We Offer :

  • Competitive compensation and annual performance bonus
  • Merit-based annual salary increases
  • Medical, dental, and vision benefits starting Day 1
  • Generous paid time off and designated holidays
  • 401(k) with company match
  • Tuition reimbursement
  • Employee referral bonus
  • Career development and advancement opportunities
  • Other :

  • Relocation assistance is not provided
  • Must be legally authorized to work in the United States now and in the future, without sponsorship
  • Must be able to pass a comprehensive background check, which includes a drug screening
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    Senior Manager Quality • Plainville, MA, US

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