Data Integrity Compliance Officer
Company: Thermo Fisher Scientific
Posted on: November 23, 2021
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
- 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
- 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
- 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
- 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
- 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,
- Ability to interface and effectively influence all levels of
- 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
- 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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