(#2989526) J&J Innovative Medicine - DI Program Lead

ProPharma; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Equal Opportunity Employer

Job summary

ProPharma seeks a seasoned Data Integrity consultant to advance governance and DI maturity across regulatory-lab environments. The role focuses on strategy, assessment, and remediation planning within GxP labs, collaborating with Quality, IT, and Manufacturing teams.

Ideal candidates will have 10+ years in pharma/biotech, 5+ years leading DI programs, and a proven track record in DI transformations, gap analyses, and remediation programs in regulated settings.

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.
• Proven track record assessing DI maturity, performing gap assessments, and executing remediation programs.

Responsibilities

• Lead Data Integrity assessment, strategy development, governance implementation, and remediation planning.
• Collaborate with site stakeholders to strengthen DI controls and strengthen inspection readiness.
• Develop governance framework and operating model for DI program across Quality, IT, and Lab operations.
• Oversee CAPA processes and remediation activities while ensuring regulatory alignment.

Skills

Data integrity assessments

Governance framework design

Operating model design

CAPA & remediation management

Stakeholder engagement

Inspection readiness & audit support

Tools

LabWare

LabVantage

STARLIMS

Waters Empower

CSV/CSA

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

#LI-JH1#LI-ONSITE

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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you’re successful or not.

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.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***