Computer System Validation Specialist - Basildon - Hybrid - Pharmanovia
About the Company
Pharmanovia is a fast-growing global speciality pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Since our founding in 2013, we have focused on revitalising niche, trusted medicines to improve patient outcomes worldwide. Our team of over 300 colleagues across 29 nationalities operates from offices in the UK, Denmark, the Netherlands, Switzerland, Italy, Spain, Germany, the UAE, India, Australia and Singapore. We are committed to delivering quality, innovation, and responsible lifecycle management of established medicines across our core therapeutic areas: Cardiovascular, Oncology, Endocrinology, and Neurology.
About the Role
We are looking for an experienced Computerised Systems Compliance Manager to help safeguard patient safety through GxP compliance and data integrity.
Responsibilities
- Provide overall compliance oversight for all GxP computerised systems across Pharmanovia
- Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance
- Develop, implement and maintain computerised systems validation and lifecycle management processes
- Act as the organisation’s subject matter expert (SME) and primary point of contact for computerised systems compliance
- Own and maintain the Site Validation Master File and validation documentation
- Lead and support internal, client and regulatory audits relating to computerised systems
- Review and approve system implementation plans, upgrades and change control activities
- Identify compliance gaps and support remediation, CAPA planning, and execution
- Conduct and communicate risk assessments associated with computerised systems
- Establish and report KPIs related to computerised systems at Quality Review Meetings
- Support supplier and system onboarding due diligence from a compliance perspective
Qualifications
Essential Experience & Knowledge
- Demonstrated experience managing computerised systems validation in a pharmaceutical, biotech, or life sciences environment, with a strong focus on GxP compliance and validation processes.
- Must have 3-5 years of experience working with Trackwise Digital.
- Experience with leading EQMS & ERP systems with a strong background in system administration and user experience.
- Computer system validation, along with lifecycle management of these systems, is essential.
- Previous QA experience in the management of (CAPA, Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls,
Strong knowledge of:
- Good Manufacturing Practice (GMP) and GxP
- EU Annex 11
- 21 CFR Part 11
- GAMP 5
- Data integrity principles and MHRA expectations
- Experience supporting or leading regulatory inspections and audits
Required Skills
- Ability to translate complex technical and regulatory concepts into clear, practical guidance
- Strong stakeholder management and cross-functional collaboration skills
- High attention to detail and strong documentation practices
- Ability to work independently while influencing multiple levels of the organisation
- Professional, reliable and committed to maintaining quality and compliance standards
Why Join Pharmanovia
- Be part of a growing global pharmaceutical organisation with a strong pipeline and expanding footprint
- Work in a collaborative, people-focused culture that encourages innovation and accountability
- Play a key role in ensuring patient safety and regulatory compliance across a diverse portfolio of established medicines
Equal Opportunity Statement
Pharmanovia is committed to diversity and inclusivity.