Convatec
CSV Senior Compliance Advisor
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Position Overview
The CSV Senior Compliance Advisor plays a key role in ensuring that IT-managed GxP computerized systems and infrastructure are validated or qualified in line with corporate quality standards and applicable regulatory requirements. This role oversees GxP-impacting projects for new or revised computerized systems, helping to ensure solutions are inspection-ready, compliant, fit for purpose, and aligned with user requirements.
Key Responsibilities:
-
Implementation Projects
- Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system
- Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.
- Oversee and/or assists in the development of validation deliverables including:
- Validation Plans
- Test Plans/Protocols/Scripts
- Specifications and Design Documents
- Compliance Assessments
- Risk Assessments
- Installation Qualification
- System and User Acceptance Testing
- Data Migration Plans
- Traceability Matrices
- Validation Reports
- Supplier Assessments
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
- Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use, and maintenance of computerized systems which support the development, manufacture, and distribution of products in alignment with applicable company policies and regulations.
- Coach the implementation teams in the proper execution of validation documents
- Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls.
- Ensure initiation/preparation and closeout of all CSV related deviations.
- Supply accurate KPIs to management on Project compliance status
-
System Maintenance
- Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
- Ensure all changes are implemented and documented in a compliant manner.
- Perform periodic assessment to review and confirm validated status.
- Perform periodic re-validations.
-
Quality Management
- Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies, and change control documents.
- Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
- Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course.
- Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk-based approaches to delivery taking into account the output of the supplier assessment.
- Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the delivery teams and wider business.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Skills & Experience:
- Minimum of 5 years’ experience in CSV validation lifecycle management, including the development and maintenance of validation documentation for computerized systems used to support healthcare products.
- Minimum of 2 years’ experience in the pharmaceutical manufacturing or medical device industry, in computer systems validation, process validation, QA, or compliance functions.
- Strong understanding of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, Annex 11, GAMP, and related validation guidance.
- Detailed understanding of computer system validation and infrastructure qualification, including the application of risk-based approaches.
- Experience working with electronic software applications such as EDMS, PLM, eQMS, complaint management systems, ERP systems, or similar platforms.
- Excellent communication, presentation, and writing skills, with the ability to clearly convey compliance requirements at all levels.
- Strong influencing, negotiation, and constructive challenge skills, with the ability to drive productive solutions.
- Proven ability to manage multiple CSV projects simultaneously, balancing competing priorities and maintaining quality and compliance standards in a high-pressure environment.
- Ability to adapt quickly to changing situations and manage a heavy workload with resilience, focus, and strong attention to detail.
- Conscientious and highly committed, with a strong focus on quality and compliance.
Qualifications/Education:
- Bachelor’s degree in computer science, engineering, life sciences, or a related field.
Travel Requirements
- Up to 10% of travel required (may include overnight stays)
Working Conditions
- Remote role, based in the UK.
#LI-AC2 #LI-Remote
Beware of scams
Beware of scams online or from individuals claiming to represent Convatec. A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email, or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Equal Opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics, or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec Employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin, and ulcerated tissue to supporting debilitating conditions, improved patient outcomes, and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more, please visit: http://www.convatecgroup.com.
Convatec is changing. We’re transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world. Our shared focus, and the sheer drive of our people, are giving us real momentum. They’re also making us a uniquely invigorating place to work. Join us and, whatever your role, you’ll be pushed and challenged every day. You’ll be supported too, empowered to spark and drive change where it matters most. We have a uniquely dynamic, sometimes demanding environment. But if you’re motivated, and as focused on delivering for patients as we are, it’ll bring the very best out in you. You’ll never stand still. And you might just make the biggest impact of your entire career.
If you would like to know how we intend to use your data following your application, please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills
Location