Data Integrity Manager
Thermo Fisher Scientific

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Data Integrity Manager will implement procedures, training and oversight aligned with PSG policies and global regulations to ensure the integrity of data generated to support manufacturing and testing processes. This role owns DI Plan(s) and will collaborate across functions and sites to ensure targets are met.

Discover Impactful Work:

As an active member of the site Quality Leadership Team and the Global DI Network you will implement DI practices and procedures to meet regulatory requirements. Coordinate routine DI Surveillance, weekly DI awareness topics, and monthly reporting to the site leadership team. Collaborate with cross functional teams for continuous improvement of processes to facilitate right first-time documentation.

A Day in the Life:

• Facilitate risk assessments for new and existing equipment and systems and provide strategic direction for remediation.
• Develop, own, and update procedures as necessary to ensure clear direction and understanding of data integrity principles and requirements.
• Leads data integrity training to ensure awareness and compliance to data integrity regulatory and program requirements.
• Support the change control and deviation management processes with respect to potential data integrity impact and ensure appropriate implementation actions are carried out to maintain compliance.
• Serve as the point person during client and regulatory inspections for DI.
• Supports the distributed team in special projects as assigned by management.

Key to Success:

Education

• Bachelor's degree in engineering, chemical / biological science or related technical field required.

Experience

• 7 years in a regulated industry OR 5 years with related technical knowledge including data integrity related to computer systems / data related to manufacturing equipment, QC instruments, and support equipment/systems.
• Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems preferred.
• Prior management experience preferred.

Knowledge, Skills, Abilities

• Strong understanding of current Good Manufacturing Practices and application of 21 CFR Part 11 and Annex 11.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Strong interpersonal and presentation skills with focus on influencing and team building.
• Ability to drive functional, technical, and operational excellence.
• Strong communication skills (verbal and written).
• Good autonomous problem-solving skills.
• Strong attention to detail.

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

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

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