Computer Systems Validation Specialist

Basildon - (Hybrid role: 3 days office, 2 days home per week)

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are:

• Wekeepourpromisesanddoaswesay.
• Wevalueourheritageandfosteranentrepreneurialspirit.
• Wereinvestinourfuture-inourproducts,ourbrandsandourpeople.
• Wegivebacktoourcommunities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees from 29 nationalities and operates from offices in the UK, Denmark, the Netherlands, Switzerland, Italy, Spain, Germany, the U.A.E., India, Australia, and Singapore. We are an agile, committed, and innovative global speciality pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to engage extensively with clinical communities to communicate product improvements and to prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

We are looking for an experienced Computerised Systems Compliance Manager to help safeguard patient safety through GxP compliance and data integrity.

• 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

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.
• Previous QA experience in the management of (CAPA, Deviation, Change Controls, Complaints, PQRs

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

• 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

Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual's race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.