Sr Director, Corporate Digital Quality|
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.
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.
- 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.
- 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. 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
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