Data Integrity Compliance Lead

Work Schedule

Environmental Conditions

Job Description

Data Integrity Compliance Lead

Division / Site Specific Information

Location: Ridgefield New Jersey Sterile Fill-Finish & Packaging Site

Our state-of-the-art sterile fill-finish and packaging facility in Ridgefield NJ is dedicated to meeting the growing needs of biotech and pharmaceutical drug developers. With expanded capabilities in pre-filled syringe and liquid vial manufacturing the site increases U.S. capacity to manufacture the medicines patients rely on every day.

As part of Thermo Fisher Scientifics global network Ridgefield complements our world-class contract development and manufacturing services and strengthens our sterile fill-finish footprintnow spanning seven sites worldwide including three in the U.S. (Greenville NC; Plainville MA; and Ridgefield NJ). Strategically located along the East Coast to streamline logistics and attract top talent the 360000 sq. ft. Ridgefield site plays a vital role in the global pharmaceutical supply chain with products distributed to more than 67 countries across all continents.

Discover Impactful Work:

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single dayenabling our customers to make the world healthier cleaner and safer. As the Data Integrity Compliance Lead you will serve as the site subject matter expert (SME) for data integrity ensuring compliance with global regulatory requirements and Thermo Fisher Scientific standards. You will drive a culture of integrity and quality by leading governance risk management and continuous improvement initiatives that safeguard the reliability accuracy and completeness of data across the entire leadership will directly support the safe and compliant manufacture of life-saving medicines relied upon by patients worldwide.

A Day in the Life:

• Develop and implement site-based data integrity procedures aligned with industry regulations and Thermo Fisher global policies.

• Define and monitor controls for ALCOA() principles: Attributable Legible Contemporaneous Original Accurate plus Complete Consistent Enduring and Available.

• Lead training and awareness programs to educate colleagues on data integrity best practices and compliance standards.

• Coach teams on Good Documentation Practices (GDP) for both paper and electronic records.

• Serve as site SME during regulatory inspections and internal/external audits.

• Prepare evidence packages responses and follow-up actions.

• Establish and chair Data Integrity Governance Team meetings.

• Collaborate cross-functionally to ensure data integrity throughout the data lifecycle.

• Conduct risk assessments to identify data integrity gaps across systems (e.g. LIMS ERP QMS eBatch Records Chromatography Data Systems (CDS)/Empower validation tools) and manual processes.

• Provide technical guidance on computerized system validation (CSV) data integrity by design and configuration management.

• Drive lifecycle management: data creation review/approval storage/retention archival retrieval and disposal.

• Define and monitor KPIs and metrics related to data integrity performance; report trends and improvement plans to site leadership.

• Lead investigations and remediation efforts related to data integrity events.

• Support incident management for data discrepancies data loss and cybersecurity events impacting data reliability.

• Coordinate cross-functional remediation and continuous improvement initiatives.

• Maintain current knowledge of evolving regulatory requirements (FDA EMA MHRA ICH WHO) and ensure alignment with corporate governance and change control processes.

• Contribute to global policy updates as applicable.

• May serve as the sites AI Champion within the Thermo Fisher Quality AI community.

• Drive awareness and adoption of AI-enabled tools and ensure site alignment with Thermo Fisher AI standards.

Keys to Success:

Education

• Bachelors degree in a scientific engineering or information discipline required; advanced degree preferred.

• Preferred fields of study: Chemistry Biology Microbiology Engineering or related technical discipline.

• Professional certifications valued (e.g. ASQ CQE CQA).

Experience

• 5 years of experience in GMP/GxP environments (pharmaceutical biotech medical device or food industry).

• 3 years of focused experience in Data Integrity and/or Computerized System Validation (CSV).

• Strong experience with quality systems including investigations CAPAs change control and document control.

• Demonstrated experience leading inspections audits and regulatory interactions.

• Proven experience conducting risk assessments and root cause analysis.

• Data integrity and computerized system validation expertise strongly preferred.

• Experience or demonstrated proficiency with AI-enabled tools preferred.

Knowledge Skills Abilities

Knowledge

• Strong knowledge of FDA EMA MHRA ICH WHO guidance on data integrity.

• Deep understanding of 21 CFR Parts 11/210/211/820 EU Annex 11 GAMP 5 and ALCOA().

• Comprehensive understanding of data lifecycle management and regulatory expectations.

Skills

• Proficiency in Quality Management Systems (QMS) and related software tools.

• Strong technical writing and documentation skills.

• Excellent verbal and written communication skills.

• Demonstrated project management and organizational capabilities.

• Strong analytical and problem-solving skills.

Abilities

• Ability to work independently and collaboratively in cross-functional teams.

• Strong attention to detail and customer-focused mindset.

• Ability to influence stakeholders and drive cultural change.

• Fluency in English required; additional languages valued.

Benefits:

We offer competitive remuneration annual incentive plan bonus healthcare and a comprehensive range of employee benefits.

Excellent Benefits & Total Rewards:

• Medical Dental & Vision benefits effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We foster a culture built on integrity intensity involvement and innovation.

Relocation assistance is not provided.

Must be legally authorized to work in the United States now or in the future without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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