Thermo Fisher Scientific Viral Vector Services Quality Head, Lexington in Lexington, Massachusetts
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.
This role serves as the site Quality head for Lexington, MA operations. The leader leads and manages site Quality related programs and activities to support the contract manufacturing organization and multiproduct manufacturing operations. This role oversees Quality Assurance review and approval, Product Release activities, supports Quality Systems, and Document Control. Additionally, this role is responsible for all Lexington QC activities. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.
Actively participates as a member of the Lexington Site Leadership Team and partners with the Operations management
Provide 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 managers 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
Lead and/or support establishment of electronic Quality systems for site, and in conjunction with the Lexington and Alachua (FL) quality teams
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
Bachelors degree in a scientific/technical discipline with 10+ years of experience in a quality leadership position, or 15 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 execute
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
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.
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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