External Audit Process Manager

About the role:

This position is responsible for establishing and maintaining an overall compliance framework for ConvaTec’s, assuring constant compliance and audit readiness across the entire business. The scope is focused on External Audit Process compliance and is assured via the execution of a Corporate External Audit Program that this position leads.

Your key duties and responsibilities:

Corporate Process:

Shape the External Audit Process in the organization that enable the harmonization of the process execution.
Collaborate across the organization to standardize and leverage practices and metrics across the organization.
Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance.
Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and supporting responses to Notified Body/Health Authorities as applicable.
External Audit Process:

Corporate process owner for external audit process execution, from readiness, to execution, response and tracking of commitments.
Owns corporate audit program (Procedure for inspection readiness and unannounced audit, System, Lead Site External Audit Scheduling with Health Authorities/Notified Body and Customers, Support responses, Maintain site profiles in e-system).
Supports External Audit Readiness as required.
Analyse External Audit data for systemic trends and proposal of Continuous Improvements projects/CAPAs.
Maintain a site compliance profile.
Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board.
Support Internal Audits execution as required.
Compliance and Education Program:

Develop and maintain training material to execute the External Audit Program.
Provides training/education for External Audit programs on regulations/ standards.
Keep abreast of all current regulatory and statutory expectations.
Support QMS regulation Changes/Gap assessment and implementation of new regulations/ standards.
Inspection readiness:

Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation.
Point Of Contact and provide leadership / oversight of inspection readiness, audit management, and responses for external inspection.
Ensure sites are in permanent state of inspection readiness using readiness tools.
Maintain external audit schedule and report on outcomes/results.
Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in.
Health Authority:

Provide independent review and classification of Regulatory Health Authority inspections and observations for all business units.
Support and review responses from the site to ensure robust investigation and action plans.
Support External Audits as required.
Other responsibilities:

Support additional projects as required such as Integration/Divestiture of sites
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:

Minimum of B.S., or equivalent, in a scientific/technical discipline is required.
Seven to Ten (7-10) years in the medical device and/or pharmaceutical industry.
Two to Four (2-4) years’ experience in a QA/QC role.
Practical experience and global mastery in global quality standards and regulations governing medical products.
Travel Requirements:

The position may involve occasional travel up to 25%, both domestically and overseas. Most trips will include overnight travel.
Working Conditions:

This role may be based in the UK with a remote working structure.
May need to support global discussions in different time zones.

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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United Kingdom
England
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