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Thermo Fisher Scientific Head of Quality Systems in Plainville, Massachusetts

Job Description Head of Quality Systems

The Head of Quality Systems provides quality leadership and oversight to the Plainville site Facilities, Quality Management Systems and is responsible for leading the Plainville site's Quality Systems team for QMS implementation and maintenance.

Operating within cross functional site teams you will ensure that the Quality Management System at the Plainville is deployed and maintained such that it supports the manufacture of late stage clinical and commercial production.

This position is critical in installing and maintaining a Culture of Quality as well as driving and deploying operational excellence tools and systems that empower cross functional production flow within the department and the wider Thermofisher organization.

This position requires an individual capable of partnering across the organization to manage a fast-paced project and production environment and deliver exceptional service to our clients

Viral Vector Services, Thermo Fisher Scientific

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, and we offer the expertise and resources necessary to help clients deliver innovative gene therapies. VVS is an experienced viral vector CDMO focused on process and analytical development. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need.

How will you make an impact?

You will provide the cross functional leadership, with up-to-date knowledge, and demonstrated experience driving and sustaining improvement to the Quality Management System to ensure compliance to all applicable standards and regulations (21 CFR Part 11, 21 CFR *210, 21 CFR *211, 21 CFR *600, 21 CFR *610, Eudralex Volume 4, International Council on Harmonization Quality Guidelines, and Guidance to Industry dockets, as applicable)

As a leader within the Quality team and the Plainville site, you will oversee the successful implementation of the Quality System, Quality governance, and Quality Risk Management. With your excellent communication skills you will ensure that Plainville has highly satisfied internal and external customers, and successful regulatory inspections

What will you do?

  • Implement and maintain a Culture of Quality and drive Quality Maturity across the Plainville site

  • Implement the Quality Management System as part of the Quality Plan for Plainville and form a strong partnership across the site

  • Manages to strengthen and harmonize key Quality Systems processes and works with sites in the network to streamline core processes (Management Review, Change Control, Complaint management, Deviation, CAPA).

  • Oversees Quality governance at Plainville, prepares and host Quality Management Reviews and Quality Council.

  • Manages the Quality Systems budget and resources to maximize efficiency and maintain quality/compliance at high levels.

  • Is an SME in Quality Management systems and ensures that the QMS is agile, robust and supports of manufacturing in a manner consistent with corporate standards and current regulatory requirements, and others as needed.

  • Ensures Quality System support for internal and external project and team meetings.

  • Builds and maintains expertise in the Quality Systems and wider Plainville site, including development of staff.

  • Partner with other departments to ensure that business and process owners comply to and improve the Quality System elements.

  • Establishes and maintaining the risk management program

  • Establishes and maintains an effective Documentation Control and Records Management program

  • Establishes and drives maturity of the QMS and Data Integrity programs.

  • Lead digital quality initiatives in alignment with the site quality strategy

  • Provide oversight to the training and Personal Quality Initiative programs

  • Ensure the safety of assigned areas and work practices in accordance with site and company EHS programs.

  • Establish department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics.

  • Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.

Education, Experience & Knowledge

  • BS in Life Sciences, or related biological science or related field.

  • Minimally, 7+ years' experience with Quality Management Systems

  • Preferred experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR *210, 21 CFR *211, 21 CFR *600, 21 CFR *610, Eudralex Volume 4, International Council on Harmonization Quality Guidelines, and Guidance to Industry dockets, as applicable.

  • Excellent organizational skills and attention to detail and accuracy

  • Previous management-level experience required - experienced in managing through others in a matrixed organization

  • Experience supporting health authority inspections a plus

  • Experience successfully coordinating and navigating complex issues with internal and external stakeholders

  • Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities

  • Ability to positively motivate and influence team members without line-management authority

  • Excellent communication, analytical, and organizational skills, using modern technology platforms

  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

Ability to draft and implement procedures, work instructions, and appropriate procedures for Quality processes.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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