CSV Senior Compliance Advisor
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (37.0%).
Occupation Type
Quality assurance and regulatory professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£48,200
(£24.72 per hour)
Occupation rate applies
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Description
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 more than 10,000 colleagues, we provide our 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 and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 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 has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from late 2027/early 2028, alongside a significant expansion of our facilities in Boston.
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 more than 10,000 colleagues, we provide our 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 and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 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 has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from late 2027/early 2028, alongside a significant expansion of our facilities in Boston.
An exciting future in Manchester
The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting-edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state-of-the-art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions.
About The Role
The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, are validated or qualified in accordance with corporate quality standards.
Key Responsibilities
The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
Your Contributions (include, but are not limited to):
Implementation Projects:
The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting-edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state-of-the-art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions.
About The Role
The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, are validated or qualified in accordance with corporate quality standards.
Key Responsibilities
The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
Your Contributions (include, but are not limited to):
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
- 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.
- 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.
- Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.)
- Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
- Detailed understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches.
- Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
- Ability to rapidly adapt to new situations and environments.
- Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
- Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
- Bachelor’s degree in computer science, engineering life science or related field.
- 5 years experience with CSV validation lifecycle management and validation documentation development.
- Minimum 2 years experience with CSV, process validation, QA or compliance functions in pharmaceutical or Medical Device industry.
- Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc.
- Excellent presentation and writing skills.
- Up to 10% travel required (may include overnight stays)
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.
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!
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!