Talent.com
Senior Manager Quality Operations and Systems

Senior Manager Quality Operations and Systems

Thermo FisherPlainville, MA, US
24 days ago
Job type
  • Full-time
Job description

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
  • Create a job alert for this search

    Operation Manager • Plainville, MA, US

    Related jobs
    • Promoted
    Sr. Director Systems Quality

    Sr. Director Systems Quality

    SharkNinjaNeedham, MA, US
    Full-time
    SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world.Powere...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Director

    Quality Director

    Gilbane Building CompanyBoston, MA, US
    Full-time
    Director of Quality is responsible for leading and managing the quality assurance strategy across all field operations for Gilbane Building Company. This role ensures that construction practices mee...Show moreLast updated: 20 days ago
    • Promoted
    Product Manager

    Product Manager

    SmartappEast Greenwich, RI, US
    Full-time
    Job Title : Product Manager (on-site).We are a US-headquartered global product software company with offices located worldwide, our HQ is located in Rhode Island. We work with marquee customers who a...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager, GMP Operational Quality

    Senior Manager, GMP Operational Quality

    VertexBoston, MA, US
    Full-time
    Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance.Quality Manager coordinates or executes activities on multiple complex projec...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Operations Manager (Relocation Required)

    Senior Operations Manager (Relocation Required)

    CarvanaFramingham, MA, US
    Full-time
    This position requires relocation after training in a specific site •.The role oversees multiple reconditioning lines and is responsible to ensure necessary production metrics are consistently met.O...Show moreLast updated: 30+ days ago
    • Promoted
    Manager Quality, Operations - Onsite - Marlborough, MA

    Manager Quality, Operations - Onsite - Marlborough, MA

    USA JobsMarlborough, MA, US
    Full-time
    Sartorius is seeking a Manager, Quality Operations, to join our team in delivering high-quality products to customers worldwide. As the Manager, Quality Operations, you will play a key role in uphol...Show moreLast updated: 2 days ago
    • Promoted
    Sr. Manager, Quality and Regulatory

    Sr. Manager, Quality and Regulatory

    COLE-PARMER INSTRUMENT COMPANYFranklin, MA, US
    Full-time
    Manager, Quality and Regulatory Assurance.Position Location : Franklin, MA.FLSA Status (Exempt / Non-Exempt) : FLSA Status : Exempt. The Senior Manager, Quality and Regulatory Assurance position is respo...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager, Global Strategic Sourcing, Technical Operations & Quality (Facilities Management)

    Senior Manager, Global Strategic Sourcing, Technical Operations & Quality (Facilities Management)

    Alnylam PharmaceuticalsCambridge, MA, United States
    Full-time
    The Senior Manager of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility for managing and optimizing external spending categories supporting the TOQ organization within th...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Quality Systems Manager, Design Quality Center of Expertise

    Senior Quality Systems Manager, Design Quality Center of Expertise

    Medtronic PlcBoston, MA, US
    Full-time
    Senior Quality Systems Manager.At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, bre...Show moreLast updated: 9 days ago
    • Promoted
    Operations Manager - Warehouse (Quality Beverage)

    Operations Manager - Warehouse (Quality Beverage)

    Quality BeverageTaunton, MA, US
    Full-time
    The primary purpose of this position is to oversee the daily activities of the warehouse / delivery operation.This position provides operational direction and leadership to all associates supporting ...Show moreLast updated: 28 days ago
    • Promoted
    Senior Manager, Quality and Regulatory - MA - On Site

    Senior Manager, Quality and Regulatory - MA - On Site

    VensureFranklin, MA, US
    Full-time
    Senior Manager, Quality And Regulatory Assurance.Position Summary The Senior Manager, Quality and Regulatory Assurance position is responsible for the implementation and execution of the Quality pr...Show moreLast updated: 8 days ago
    • Promoted
    Senior Director, Quality Management Systems and Digital Compliance

    Senior Director, Quality Management Systems and Digital Compliance

    Intellia TherapeuticsCambridge, MA, US
    Full-time
    Senior Director QMS And Digital Compliance.Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening dis...Show moreLast updated: 21 days ago
    • Promoted
    Senior Manager of Biomarker Operational Quality

    Senior Manager of Biomarker Operational Quality

    Clear Point ConsultantsBoston, MA, United States
    Full-time
    As the Senior Manager of Biomarker Operational Quality, you’ll be the go-to person for making sure biomarker-related work across research, clinical trials, and potential commercial use stays aligne...Show moreLast updated: 1 day ago
    • Promoted
    Director, Quant Development (Backtesting)

    Director, Quant Development (Backtesting)

    Fidelity InvestmentsSmithfield, RI, US
    Full-time
    Director Quant Development, Backtesting.We are seeking Director Quant Development to join our Quantitative Research & Investments Technology (QRIT) team in Fidelity Asset Management Technology....Show moreLast updated: 2 days ago
    • Promoted
    Senior Product Manager, Global Product Management

    Senior Product Manager, Global Product Management

    COLE-PARMER INSTRUMENT COMPANYFranklin, MA, US
    Full-time
    Senior Product Manager, Global Product Management.Reports To : VP, Global Product Marketing, ZeptoMetrix.Position Location : Buffalo, NY Franklin, MA highly preferred. FLSA Status (Exempt / Non-Exempt) : ...Show moreLast updated: 30+ days ago
    • Promoted
    Sr. Manager, R&D Quality Operations & Compliance

    Sr. Manager, R&D Quality Operations & Compliance

    BiogenCambridge, MA, US
    Full-time
    Senior Manager, R&D Quality Operations and Compliance (QOC).The Senior Manager, R&D Quality Operations and Compliance (QOC), serves as a Functional Quality Representative (FQR) and plays a key role...Show moreLast updated: 30+ days ago
    • Promoted
    Operations Quality Manager

    Operations Quality Manager

    WatersMilford, MA, US
    Full-time
    The Operations Quality Manager reports to the Regional Quality Director, Americas.Responsibilities of the role include supporting all Quality activities in Milford Assembly and Kitting, the Frankli...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager, Quality Engineering

    Senior Manager, Quality Engineering

    BeviBoston, MA, US
    Full-time
    Senior Manager, Quality Engineering.Bevi is on a mission to transform how beverages are delivered and consumed.Our smart hydration systems eliminate the need for single-use bottles and cansmaking i...Show moreLast updated: 14 days ago