Supervisor, Quality Control

---

Job description

Job Description

Job Title: Supervisor, Quality Control

Requisition ID: 169841BR

Relocation has been approved for this role

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of over $28 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information:

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. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

This position will be based at the Somerville, MA site.

How will you make an impact?

By overseeing the Somerville Quality Control specifications team, this role is responsible for the development and continuous improvement of the VVS raw material specification and qualification program. You will drive phase appropriate solutions to enable a fit for use process at the Somerville site. The candidate will also be responsible for implementing Operational Excellence solutions to optimize the specification and raw material qualification program.

What will you do?

* Lead and develop a high performing technical documentation team within the Somerville quality organization.

* Serve as a matrix leader to ensure VVS business needs are met while driving compliant, fit for purpose specification and raw material qualification solutions.

* Lead the development, maintenance and improvement of Quality standards related to specifications, SOPs, work instructions/OJTs and material qualification. Ensure all Quality standards align with regulatory and company policies, directives and guidance.

* Manage the technical documentation team to assure on-time specification generation, material onboarding assessment and specification effectiveness to meet VVS business needs for clients and internal stakeholders at multiple sites.

* Oversee the creation of raw material qualification reports.

* Participate in the supplier selection and qualification process.

* Champion and drive improvement for specifications, SOPs, work instructions/OJTs and material qualification processes to assure that they are efficient and effective.

* Develop and implement Operational Excellence solutions to improve the efficiency of the Somerville Quality organization.

* As required, author, review and approve Quality records including deviations, CAPA, change controls, risk assessment and technical reports.

How will you get here?

Education & Experience:

* Bachelor's degree in chemical/biomedical/manufacturing engineering, molecular biology/virology, quality assurance, quality control or a related field and 4+ years experience.

* Experience to include 3+ years with FDA and/or EMA regulated manufacturing, MS&T, QA, or QC organizations.

* Demonstrated people management or matrix leadership experience is strongly preferred.

* Experience with Operational Excellence or Lean Principles preferred.

* Direct experience interacting with FDA and/or EMA during inspections is preferred.

Knowledge, Skills, Abilities:

* Exceptional talent for clear technical communication to diverse internal and external stakeholders to drive decision making.

* Strong project management skills including proven ability to lead matrix teams to deliver projects and grow project management skills within teams.

* Experience and leadership in FDA, EMA oversight including investigations, CAPA, and audits.

* Leader with ability to grow and retain teams. Emphasis on building consensus, driving performance, and owning decisions made by teams of diverse stakeholders.

* Working knowledge of current GxP laboratory practices and procedures, preferably related to material quality testing.

* Knowledge of QC testing principles and procedures, including compendial requirements (ex. USP/NF, Ph. Eur, JP).

* Knowledge of ICH guidelines for analytical methods and validation.

* Experience in developing sampling processes, testing and/or inspection specifications and release procedures for raw materials and components.

* Strong accountability and ability to manage an extensive book of work is required.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

<!– job description page –>