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.
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.***
