Data Integrity Compliance Lead
Job Description :
When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help 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
At the Plainville, MA site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies.
How will you make an impact?
Initiates, implements, maintains, and improves the Data Integrity according to the company Quality policies and the applicable regulations to create superior health care products. Ensures integrity of laboratory generated data and ensures laboratory investigations are carried out in accordance with regulatory expectations. Drives continuous quality and operational excellence improvements.
What will you do?
- Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards. Establishes operational objectives and assists with developing, modifying, and executing company policies.
- Ensures all new and existing equipment and systems are assessed appropriately and validated for its intended use and existence. Coordinates procedure/process testing and provides reviews of audit trails.
- Provides gap assessments and status updates to senior management to maintain and improve data integrity. Conducts monthly DI surveillance, provides weekly DI awareness, and reports findings to SLT.
- Supports generation of risk assessments to identify high risk equipment/systems and implementation of appropriate corrective action.
- Leads site data integrity governance, departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper and electronic records, and good documentation practices.
- Develops, owns, and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities, and the importance of corporate and regulatory requirements for data integrity compliance.
- Supports creation and execution of change controls and establishes user requirements for laboratory and operations equipment.
- Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
How will you get here?
Education
- Bachelor’s degree in engineering or biological sciences or related technical field.
Experience
- At least 5 years experience in a regulated industry or 3 years with related technical knowledge including data integrity related to data from quality control testing, chromatographic systems, laboratory metrology, instrumentation compliance, manufacturing equipment and systems.
- Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals to keep to timelines and meet internal/external commitments
- Strong writing and record keeping
- Project Management and/or prior management experience preferred.
Knowledge, Skills, Abilities
- Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Expert knowledge of laboratory instrumentation and/or operations equipment.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Effective written, interpersonal, and presentation skills.
- Ability to work on multiple projects simultaneously.
- Ability to drive functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
At Thermo Fisher Scientific, each one of our 80,000 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.
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.