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Thermo Fisher Scientific Sr Director, Corporate Digital Quality in Boston, Massachusetts

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 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 efficiency in their laboratories, we are here to support them. Our team of more than 100,000 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, Patheon and PPD. For more information, please visit www.thermofisher.com .

POSITION SUMMARY:

The position has responsibilities and focus on the advancement and sustainability of digital solutions used in Global Quality and Regulatory Affairs.

Specific role responsibilities include general system (digital) ownership, computer system assurance oversight, enterprise wide solution governance, policy/procedure development, advocacy, and strategic plan development.

Key Responsibilities:

  • Act as formal project manager for identification and deployment of Digital Quality & Regulatory Systems.

  • Act as Business Owner and Compliance reviewer for Enterprise Wide Solutions supported through the Corporate IT organization.

  • Creation of Policy and Guidance documents stemming from promulgated regulations and standards (e.g. NIST, AAMI, ISO, GAMP, FDA Guidance)

  • Provide consultancy and strategic direction to all businesses across company on harmonization, standardization, and rationalization of future, current and aging IT/computer systems.

  • Engage with Corporate Information Security and the Global Data Privacy Organization to implement Cybersecurity and data privacy policies, guidance, and procedures.

Qualifications:

  • 15+ years of shown experience with growing roles of responsibility for the automation of Quality and Regulatory processes.

  • Bachelor's degree from an accredited college/university in a science related subject area.

  • Validated commitment to delivering to timelines and milestones to achieve project/business objectives.

  • Excellent communication and listening skills.

  • Ability to maintain an executive presence and communicate well with senior leadership.

  • Ability to build and maintain strong collaborative relationships across multiple departments.

  • Commitment and intensity to get the work completed with a string sense of innovation.

  • Working knowledge of cGMPs and global regulations (e.g., FDA 21 CFR Part 11, FDA 21 CFR Part 210, 211, 820, EudraLex , etc.) and quality systems in Medical Device and Pharmaceutical industry.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

  • This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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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