Quality Compliance Lead

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About Us
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 around 10,000 colleagues, we provide our products and services in almost 100 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. Group revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as Quality Compliance Lead, and you’ll do the same.

About the role:
This position will have the objective of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Manufacturing Quality Compliance.
Your key duties and responsibilities:
Oversight & coordination of GMP inspections of controlled environments.
Oversight & coordination of inspections / audits of business-critical processes.
Education & training for production / engineering team members in compliance issues.
Supporting GMP improvement projects.
Develop the manufacturing site towards “Audit Ready At All Times”.
Performs and lead GMP walks / process inspections.
Track GMP issues identified and work with site management to correct and prevent.
Provide leadership, support and guidance to drive successful execution of the Internal Audit Process at Deeside Manufacturing site.
Generate the audit schedule for Deeside Manufacturing with appropriate input from site Quality Leadership and other stakeholders.
Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements.
Gather and analyse data as an input to the Management Reviews to allow meaningful review.
Support Internal Audit as required.
Provide training & education activities to support induction activities & ongoing employee training / development.
Maintenance of the Intra Company Quality Agreements as required.
Support other projects as required by the business.
Skills & Experience:
Internal Lead Auditor Certification and experience in executing audits.
Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style.
Ability to build and nurture strong and positive relationships with other leaders to partner effectively.
Balanced technical understanding of products and processes combined with business and compliance acumen.
Qualifications/Education:
Two to Four (2-4) years’ experience in a QA/QC role in medical device and/or pharmaceutical industry.
ISO 13485 Internal auditor (Lead auditor preferred).
Working Conditions:
Office based, predominantly on days, however flexibility is required to work with nights / weekends teams as required.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll

move

you.
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#LI-Onsite
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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 .
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.

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