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Data Integrity Compliance Officer

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: November 23, 2021

Job Description:

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.Location/Division Specific InformationThermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.How will you make an impact?Lead a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure all CGxP data is collected, protected, archived, preserved, and retrievable according to industry and regulatory guidelines. Ensure the Research/Quality Operations have awareness of Data Integrity as it relates to paper and electronic records and ensure good documentation practices for electronic and paper based data are in place. The position will coordinate and facilitate meetings with cross-functional groups to discuss data integrity. This position will be responsible for ensuring the Cambridge and Somerville site operate under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement. The Data Integrity Compliance Officer is the point person during regulatory inspections for Data integrity and plays a major role in regulatory and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place for Thermo Fisher Scientific to maintain its license to operate.What will you do?

  • Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed; meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
  • 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 is 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.
  • Supports risk assessments to determine high risk equipment and determines appropriate corrective action.
  • Leads 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, manages, 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.
  • Leads and establishes, where necessary, a surveillance program to audit all laboratory and operational practices and staff for compliance with established documentation and data integrity standards, practices and proceduresHow will you get there?Education
    • BS/BA degree in chemical, biological sciences, engineering or related field.Preferred QualificationsIdeal candidates will possess the following, but they are not required for consideration.
      • Advanced degree or certification
      • Previous experience in a supervisory role.
      • Project Management and/or prior management experience preferred.
        • 7+ years experience in a highly-regulated industry (i.e.: Food, Drug or Medical devices) or 5+ years with related technical knowledge including data integrity related to quality control data from chromatographic systems, laboratory metrology, instrumentation compliance, manufacturing equipment and systems.Knowledge, Skills, Abilities
          • Ability to interface and effectively influence all levels of the organization.
          • Proficient computer skills with a desired knowledge of Word, PowerPoint, and Excel.
          • Strong interpersonal, communication, and presentation skills with a focus on coaching and influencing others.
          • Excellent written and verbal communication skills.
          • Fluency in English.
          • Ability to travel --- 10% on an annual basis.
          • Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
          • Expert knowledge of laboratory instrumentation and/or operations equipment.
          • Ability to drive functional, technical and operational excellence.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.

Keywords: Thermo Fisher Scientific, Cambridge , Data Integrity Compliance Officer, Other , Cambridge, Massachusetts

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