Thermo Fisher Scientific Job - 39556635 | CareerArc
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Company: Thermo Fisher Scientific
Location: Plainville, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job Description Head of QA Operations

The Head of Quality Assurance provides quality leadership and compliance oversight to internal and external customers, and is responsible for leading the Plainville site's Quality Assurance team for facility start-up, commissions, qualification and operations.

Operating within cross functional site teams you will provide expert input into quality issues associated in support 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, Quality expertise in cGMP US regulation, EU and rest of world guidance, which enables Plainville to reliably meet and/or exceed product supply targets while achieving high levels of quality.

As a leader within the Quality team and the Plainville site, you will oversee the QA Operations budget, aide in the implementation and maintenance of the Quality Management System. 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
  • Aide in the implement the Quality Plan for Plainville and form a strong partnership across the site
  • Oversees all aspects of QA operations within the facility, including but not limited to executed batch record review, on the floor QA support, material release, deviation investigations, change controls, customer quality support and SOP and master batch record review.
  • Responsible for release of bulk drug substance and drug product batches.
  • Implement robust business processes to support the Right First Time execution of batch records, ensure timely disposition of Raw Materials, Drug Substance and Drug Product, and oversee execution of robust investigation leading to effective Corrective and Preventative Actions.
  • Manages the budget and resources to maximize efficiency and maintain quality/compliance at high levels.
  • Develops, directs, and maintains quality systems in support of manufacturing in a manner consistent with global quality systems requirements, corporate standards and current regulatory requirements, and others as needed. Quality systems include but are not limited to audits and inspections, documentation and records management.
  • Ensures QA support for internal and external project and team meetings.
  • Has decision-making authority for any Quality issues; informs Site Quality Head of critical issues in a timely manner.
  • Builds and maintains expertise in the QA Ops teams, including development of staff. Applies biologics manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing at all phases of product development.
  • 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 Biological Science or related field.
  • At least 7+ years of related experience in the Quality Unit.
  • Extensive exposure to cGMP environment.
  • Strong organizational and time management skills. Prioritization and problem-solving skills.
  • Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.
  • Experience leading conversations with customers (internal and external).
  • Strong interpersonal and communications skills; written and oral.
  • Understanding of applicable regulatory requirements.
  • While performing the duties of this job, the employee:
  • Demonstrate excellent organization and time management skills.
  • Needs Ability to aseptically gown and/or sterile gown as needed
  • Ability to function in a dynamic environment and balance multiple priorities simultaneously

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