Sr Director of Quality, Plainville

Thermo Fisher Scientific Plainville, MA

About the Job

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 www.thermofisher.com.

The Senior Director of Quality serves as the site Quality head for Viral Vector Services Plainville Operations. The individual will provide leadership and guidance 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 compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints
  • Manages team of leaders and professionals within Quality. Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions
  • Supports development of appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement
  • Accountable for regulatory inspections and client audits
  • Support establishment and/or enhancement 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 Quality 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 organizational skills; ability to prioritize and manage through complex 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 effectively 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 deal with abstract and concrete variables in situations where only limited standardization exists
  • Ability to utilize various standard programs for data entry and word processing
  • Ability to utilize software and customized programs to meet business needs
Qualifications:
  • Bachelors degree in a scientific/technical discipline with 15+ years of experience in a quality leadership position, or >20 years progressive 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 communication skills
  • Ability to multitask, strategically and tactically
  • Solid knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
  • Ability to apply GMP regulations and international guidelines to all aspects of the position
  • Proven leadership in managing complex regulatory topics and interactions

PHYSICAL DEMANDS
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously

At Thermo Fisher Scientific, each one of our 75,000 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.