Data Integrity Compliance Lead

Thermo Fisher Scientific • Teterboro, NJ

2d • Onsite

About The Position

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—enabling 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 lifecycle.Your leadership will directly support the safe and compliant manufacture of life-saving medicines relied upon by patients worldwide.

Requirements

• Bachelor’s degree in a scientific, engineering, or information discipline required; advanced degree preferred.
• 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.
• 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.
• 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.
• 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.

Nice To Haves

• Preferred fields of study: Chemistry, Biology, Microbiology, Engineering, or related technical discipline.
• Professional certifications valued (e.g., ASQ CQE, CQA).
• Data integrity and computerized system validation expertise strongly preferred.
• Experience or demonstrated proficiency with AI-enabled tools preferred.

Responsibilities

• 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 site’s 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.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a comprehensive range of employee benefits.
• Medical, Dental, & Vision benefits effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level