Data Integrity Program Lead Consultant

PPG UK ProPharma Group MIS; United States; Hybrid; USD 110,000 - 170,000; Full time

Job summary

ProPharma is seeking an experienced Data Integrity Consultant to support DI planning and governance across regulated laboratories. You will assess DI maturity, map data flows, and develop remediation roadmaps aligned with regulatory expectations.

Collaboration with Quality, IT, and Manufacturing will be key to strengthening controls and inspection readiness. The role involves cross-functional engagement, overseeing CAPA activities, and enabling a sustainable governance model across sites, with

Qualifications

• 10+ years in pharmaceutical, biotechnology, or medical device industries.
• 5+ years leading enterprise or site-level Data Integrity programs.
• Experience driving Data Integrity transformations within GxP-regulated laboratories.

Responsibilities

• Support Data Integrity planning and governance for the labs DI transformation initiative.
• Develop and implement governance framework and remediation roadmaps.
• Perform DI maturity assessments, gap analyses, and CAPA planning.
• Engage stakeholders across Quality, IT, Laboratory Operations, and Manufacturing; support inspections.

Skills

Data integrity assessments

Risk evaluations

Governance framework development

Operating model design

CAPA and remediation management

Stakeholder engagement

Inspection readiness

Tools

LIMS (LabWare)

LIMS (LabVantage)

LIMS (STARLIMS)

CDS (Waters Empower)

ELN

SDMS

CSV/CSA

ICH Q9

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Scope

Clients Small Molecule Stability Team is looking for outside assistance with their Data Integrity planning and governance. Consultant will support the labs Data Integrity transformation initiative through assessment, strategy development, governance implementation, and remediation planning. Activities may include Data Integrity maturity and risk assessments, data flow and process mapping, equipment and system evaluations, Annex 11 readiness reviews, governance framework development, and remediation roadmap creation. Consultant will work collaboratively with site stakeholders to strengthen Data Integrity controls, improve inspection readiness, enhance laboratory system integration, and establish a sustainable site-level governance model aligned with regulatory expectations and industry best practices.

Core Experience

• 10+ years in pharmaceutical, biotechnology, or medical device industries
• 5+ years leading enterprise or site-level Data Integrity programs
• Experience driving Data Integrity transformations within GxP-regulated laboratories
• Proven track record assessing DI maturity, performing gap assessments, and executing remediation programs

Regulatory Expertise

• FDA Data Integrity Guidance
• MHRA Data Integrity Guidance
• EU GMP Annex 11
• PIC/S Data Integrity Guidance
• ALCOA+ principles
• GMP/GxP compliance requirements

Laboratory Background

• Quality Control (QC)
• Analytical Development
• Stability Laboratories
• Manufacturing Support Laboratories

Key Skills

• Data Integrity assessments and risk evaluations
• Governance framework development
• Operating model design
• CAPA and remediation management
• Stakeholder engagement across Quality, IT, Laboratory Operations, and Manufacturing
• Inspection readiness and audit support

Highly Desired Technical Experience

• LIMS: LabWare, LabVantage, STARLIMS
• Chromatography Data Systems (CDS): Waters Empower
• ELN: Electronic Laboratory Notebooks
• SDMS: Scientific Data Management Systems
• Computer System Validation (CSV) / Computer Software Assurance (CSA)
• ICH Q9 Risk Management

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.