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Job Description
- Req#: JR00014814
- Shape the Internal 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.
- The position provides leadership, oversight, and strategic guidance for companywide issues related to Quality Compliance.
- Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements.
- Liaise with Quality Leaders on assessing gaps and defining actions plans related to Internal Audit NonConformances
- Support Corporate Audits as required.
- Process owner of the Corporate Internal Audit process (Owns Procedure, Ensure TrackWise System development, maintenance, and execution, establish and maintain site internal audit schedules, assign auditors to internal audits, owns auditor qualification program.
- Ensure robust investigation of audit observations and adequate CAPA action plans, ensure alignment in audit non-conformance ratings.
- Analyze Internal Audit data for systemic trends, drive compliance and improvement in internal audit metrics.
- Gather and analyze data as an input to the Management Reviews to allow meaningful review.
- Support Internal Audits execution as required.
- Develop and maintain training material to execute the Internal Audit Program.
- Provides training/education for internal auditors, provide and develop compliance education trainings (QSR, ISO, GMPs), coach and mentor Internal Auditors.
- Lead Monthly meetings to share best practices and ensure continuous education.
- Keep abreast of all current regulatory and statutory expectations.
- Support Regulation/Standard Gap Assessments and implementation as required.
- Support External Audits and responses as needed People Management of one direct report.
- Managing day to day activities.
- Assigning tasks
- Providing guidance and support
- Evaluating performance
- Internal Lead Auditor Certification and extensive 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.
- Ability to coach and develop others to deliver best in class practices.
- Minimum of B.S., or equivalent, in a scientific/technical discipline is required.
- Minimum 5 years’ experience in the medical device and/or pharmaceutical industry.
- Minimum 4 years’ experience in a QA/QC role.
- Practical experience and global mastery in global quality standards and regulations governing medical products.
- This role may be based in the United Kingdom with a remote working structure - office presence will be required or allowed for certain meetings, events, or to meet certain business needs.
- Minimal travel, less than 20% within Europe but overseas travel is expected.
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 http://www.convatecgroup.com
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 an Internal Audit Process Manager, 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 Internal Audit Process compliance and is assured via the execution of a Corporate Internal Audit Program that this position leads.
Your key duties and responsibilities:
Corporate Internal Audit Process:
Internal Audit Program and Management Execution:
Compliance and Education Program:
Health Authority:
Quality Compliance Engineer:
Skills & Experience:
Qualifications/Education:
Working Conditions:
Travel Requirements:
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.
#LI-CC1
#LI-Remote
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.
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 the company
ConvaTec products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.