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Thermo Fisher Scientific Director Quality in Plainville, Massachusetts

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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 sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.

The Director serves as the site Quality head for Viral Vector Services, Plainville, MA. The individual will provide leadership to the Quality Unit and work through the Quality Department heads within the Quality function at Plainville. Responsibilities include developing strategies, leading programs and activities to support the contract manufacturing organization and multiproduct manufacturing operations. The quality functions are comprised of QC, QA, QS, Compliance, QAV, to support review and approval, Product Release activities and integration and all operations oversight. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Key Responsibilities:

  • Actively participates as a member of the Quality Leadership Team and partners with the Operations management

  • Provides strategy, operational leadership and expertise in the development, implementation, and training of cGMP systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints

  • Leads team of professionals within Quality.

  • Supports development of appropriate operating and capital expense budgets and strives to have the Quality organization supply to COGS improvement

  • Accountable for regulatory inspections and client audits

  • Support establishment and/or improvement of Quality metrics and mitigation strategies where appropriate

  • Leads and/or supports establishment of electronic Quality systems for site, and in conjunction

  • Evaluates the functional strengths and developmental areas in the organization and focuses on continuous improvement

  • Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed in order to proactively support business processes

Knowledge, Skills, and Abilities

  • Ability to write reports, business correspondence and procedure manuals

  • Strong ability to prioritize and handle through sophisticated processes/projects

  • Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents

  • Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

  • Ability to efficiently present information to employees, top management, public groups and/or boards of directors

  • Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form

  • Ability to define problems, collect data, establish facts and draw valid conclusions

  • Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems

  • Ability to look after abstract and concrete variables in situations where only limited standardization exists

  • Experience with various standard programs for data entry and word processing

  • Ability to use software and customized programs to meet business needs

Qualifications:

  • Bachelors degree in a scientific/technical subject area with 10+ years shown experience in a quality leadership position, or >15 years management experience with GMP responsibilities within the biological and/or pharmaceutical industry

  • Significant experience in supporting functional areas (e.g. R&D, Manufacturing, QC, Engineering, EHS, Tech Services) preferred

  • Excellent interpersonal skills

  • Ability to multitask, strategically and tactically

  • Validated knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.

  • GMP regulations and international guidelines to all aspects of the position

  • Validated leadership in leading sophisticated regulatory topics and interactions

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.

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.

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