Data Integrity Manager

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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.

DESCRIPTION:
Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As a Data Integrity Manager, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement.

You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements. This role offers the opportunity to directly contribute to our mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes. Note: We are not able to offer relocation assistance for this role at this time.

ESSENTIAL FUNCTIONS:

• Assist in preparation of the Data Integrity (DI) Site Governance Team meetings.
• Assist with providing metrics to the Director of the Global Data Integrity network to include pulling data from TrackWise, Audits, Power BI, and other site systems.
• Monitor equipment and instrumentation as indicated in the site data integrity remediation plan and ensure it complies with 21CFR Part 11, Annex 11, and Data Integrity regulations.
• Support and lead Data Integrity initiatives across the site to maintain and proactively improve the data integrity culture.
• Coordinate and track the Data Integrity Remediation Plan to ensure deliverables are on target and executed as committed within the site.
• Provide support on the development of Data Integrity awareness training and compliance with data integrity regulations.
• Create/update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations.
• Coordinate the DI Surveillance program to audit GMP areas within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
• Collaborate on projects to meet customer, business, and regulatory requirements.
• Present DI Metrics to Site leadership monthly. Provide approvals for DI related deviations, CAPA, and change controls. Assist in data integrity risk assessments.

JOB SCOPE:

• Active member in meetings with cross-functional groups within the site and network to discuss data integrity from both a technical and cultural perspective
• Responsible for ensuring operations and laboratories operate under applicable regulatory policies for documentation and data integrity regulations/guidelines as well as striving for continuous improvement
• Uses professional concepts and company objectives to resolve complex issues in creative and effective manners
• Leads processes, projects and initiatives critical to the success of the Data Integrity program
• Interacts and networks with key contacts and the Global DI network
• Influences individuals or business groups regarding financial, equipment, and resource needs within the site

REQUIREMENTS:

• Bachelor's Degree in Chemistry, Biology, Microbiology, Engineering, or similar scientific, engineering or related technical field; Advanced degree preferred
• At least 6 - 8 years of experience in quality assurance in a GMP-regulated pharmaceutical/biotech environment
• Proven expertise in quality systems including investigations, CAPAs, change control, document control, training
• Experience with risk assessment methodologies and root cause analysis
• Experience hosting regulatory inspections and customer audits preferred
• Data integrity and computer system validation experience preferred
• Professional certifications valued (e.g. ASQ CQE, CQA)

KNOWLEDGE, SKILLS, ABILITIES:

• Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211, ICH guidelines
• Proficiency with quality management systems and standard office software
• Strong technical writing and documentation skills
• Excellent verbal/written communication and interpersonal abilities
• Demonstrated project management and organizational capabilities
• Strong analytical and problem-solving skills
• Ability to work independently and collaborate effectively in cross-functional teams
• Ability to work effectively with diverse teams
• Customer-focused mindset with strong attention to detail
• Fluency in English required; additional languages valued

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.