Data Integrity Program Lead

Overview

Overview

Our client is seeking an experienced Data Integrity Program Lead to provide strategic oversight of site-wide Data Integrity initiatives within a regulated manufacturing environment. This position will be responsible for developing and implementing the Data Integrity strategy, ensuring regulatory compliance, driving continuous improvement, and leading cross-functional projects that support operational excellence.

Responsibilities

Key Responsibilities

Develop and implement the site’s Data Integrity strategy and governance framework.
Lead Data Integrity compliance activities across the manufacturing site to ensure alignment with regulatory and corporate standards.
Develop and execute the site’s Data Integrity roadmap in line with business objectives.
Prioritise and oversee Data Integrity programmes and initiatives.
Partner with Quality Control and cross-functional teams on Data Integrity projects.
Perform assessments of new and existing systems, identifying remediation opportunities where required.
Support the successful implementation of global and local systems across the organisation.
Provide guidance on regulatory Data Integrity requirements and ensure effective communication across the business.
Promote best practice through collaboration with internal stakeholders and external industry networks.
Maintain Data Integrity maturity and continuous improvement programmes.
Lead risk assessments to identify Data Integrity vulnerabilities and implement mitigation strategies.
Coordinate cross-functional projects while managing risks, dependencies and programme priorities.
Coach and mentor employees on Data Integrity principles, investigation techniques and regulatory expectations.
Act as the site’s Data Integrity Champion, driving a culture of compliance and operational excellence.

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Compliance Responsibilities

Author, review and maintain Standard Operating Procedures (SOPs).
Deliver and support Data Integrity training programmes.
Assess systems against internal procedures and regulatory Data Integrity requirements.
Participate in investigations, deviations and CAPAs relating to Data Integrity.
Maintain the site’s Data Integrity Master Plan.
Lead Audit Trail Review (ATR) strategy and governance.
Act as Primary Process Owner for key Data Integrity programmes and quality metrics.

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Qualifications

Qualifications

Bachelor’s Degree in Science, Engineering, Information Technology or a related discipline.

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Experience

9+ years’ experience within the pharmaceutical, biotechnology or another highly regulated manufacturing environment.
5+ years’ experience leading projects or programmes.
3+ years’ experience leading Data Integrity remediation initiatives.
Strong understanding of Data Integrity regulations including EU GMP Annex 11 and 21 CFR Part 11.
Experience working within Quality, Manufacturing, QC Laboratories or Information Technology functions.