Thermo Fisher Scientific Inc.
Waltham, MA, United States
Executive, Manager, Audit, Sciences
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
The Director, Corporate Surveillance/Principal Auditor is responsible for
ensuring compliance to global governmental regulatory requirements, corporate policies, group and divisional processes and site level procedures. The goal of the program is to identify and highlight compliance gaps for management so that appropriate and timely action can be taken to reduce the overall risk to the company. The program accomplishes this through a methodical, collaborative and organized process driven by exceptionally qualified staff. The Corporate Audit Program focuses on all operations (manufacturing, logistics and commercial) that could impact Thermo Fisher Scientific’s brand, market reputation, patients, consumers and customers.
What will you do?
The role is accountable for ensuring the Company’s corporate quality audit program provides an accurate ongoing assessment of the Organization’s compliance profile across all its sites and operations including measuring compliance risk and assessing remediation needs and improvement opportunities across the enterprise. The incumbent requires significant business auditing experience as well as recent experience working with FDA and other global competent authorities.
Under her/his leadership, the Quality Audit organization examines operational and compliance activities while building an audit program with a risk-based schedule to drive execution of internal quality audits. The Quality Audit team is responsible for performing unbiased assessments and reports its findings and recommendations to senior management, thereby addressing the strength of internal control systems, enhancing the cost effectiveness and efficiency of operations and maintaining proper accountability for compliance while managing risks appropriately.
How will you get here?
Bachelor of Science Degree/STEM required. Master’s Degree preferred (not MBA)
> 10 years IVD/Med Device/Pharma Industry experience required
Practical experience building and sustaining quality systems required
>/= 5 years former FDA ORA employment required
>15 years’ total experience (minimum 5 in a leadership role) in the life sciences/healthcare industries
Recognized expert with a proven track record of 8 or more years managing and delivering best practices in the quality assurance field including Quality Audit services in large, complex, global organizations
Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices/pharma/IVD partnering with functional stakeholders and experts
Knowledge, Skills, Abilities
Knowledge of FDA GxP, 21 CFR Part 820, 803, 806, 210, 211 QSR, ISO 13485, ISO 9001 and global regulatory standards required (China, Brazil, EU)
Software auditing experience preferred
Familiarity with compliance IT systems such as TrackWise or MasterControl
Excellent problem-solving and analytical skills
Ability to interface with technical resources and scientifically based teams
Strong technical writing experience required (English)
Required Knowledge, Skills, Abilities
Adherence to our organizational values of Integrity, intensity, Innovation and Involvement
Ability to travel up to 60% of the time
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process,
for further assistance.
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 Inc.
Website : http://www.thermofisher.com