Solution Owner Quality Management System (Regulatory & Quality)

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 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

 

Position Overview

The Solution Owner Quality Management System (Regulatory & Quality) oversees the full lifecycle of management systems (Trackwise), ensuring alignment with operational needs and technological innovation. This role requires balancing technical expertise with strategic vision to optimize processes and maintain system integrity.

Key Responsibilities

• Design, configure, test, deploy, maintain, and improve applications.

• Collaborate closely with QA, IT, and business stakeholders to define system requirements and solutions. 

• Orchestrate clear, efficient, and well-documented configurations and scripts, following best practices and compliance standards. 

• Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP, 21 CFR Part 11), and data integrity. 

• Troubleshoot, debug, and upgrade existing systems to ensure optimal operations and minimal downtime. 

• Contribute to the full system lifecycle, from requirements gathering and design through deployment, training, and ongoing support. 

• Stay updated with emerging technologies and apply relevant advancements to improve system functionality.

• Work closely with QA and compliance teams to ensure that applications meet the highest quality and regulatory standards. 

• Assist in project planning, task estimation, and risk identification, proactively addressing potential issues and proposing effective solutions. 

• Provide ongoing support, training, and mentorship to users and administrators. 

Key Requirements 

• Minimum of 3-5 years of experience in IT Systems operations, with a focus on regulatory and Quality Solutions.

• Trackwise experience is required.

• Proven experience with Regulatory & Quality Systems.

• Proficient in system configuration, SLA Management and business stakeholder management.

• Strong understanding of data management and regulatory requirements (e.g., GxP, 21 CFR Part 11). 

• Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices. 

• Familiarity with database technologies (e.g., SQL) and web services (e.g., REST, SOAP). 

• Experience with version control systems (e.g., GitHub) and change management processes. 

• Excellent problem-solving and analytical skills, with attention to detail and data integrity. 

• Strong communication and teamwork abilities, with experience collaborating across functional teams. 

• Experience with cloud services and technologies is a plus. 

• Ability to lead training sessions and support end-users in a regulated environment. 

Education/ Qualifications 

• A Masters / Bachelor's degree in business, information technology, or a related field. Advanced degrees or certifications are a plus. 

• Itil 4, Prince 2 or GMP is a plus 

Travel Requirements 

• Position involves travel up to 10% of the time, mostly within Europe, Asia Pacific, and the Americas. Most trips will include overnight travel. 

Languages 

• English

• Spanish or Portuguese is a plus

Working conditions 

• Hybrid working model as Convatec has a flexible approach to office working.   

 

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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!