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 10000 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit

PositionOverview

TheSolution OwnerQuality Management System(Regulatory & Quality)oversees the full lifecycleofmanagementsystems(Trackwise) ensuring alignment with operational needs and technological innovation. This role requires balancing technicalexpertisewithstrategicvision tooptimizeprocesses andmaintainsystem integrity.

KeyResponsibilities

• Design configure test deploymaintain and improveapplications.

• Collaborate closely with QA IT and business stakeholders to define system requirementsandsolutions.

• Orchestrateclear 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 ( 21 CFR Part 11) and data integrity.

• Troubleshoot debug and upgrade existing systems to ensureoptimaloperations 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.

• Assistin 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.

KeyRequirements

• Minimum of3-5years of experience inIT Systemsoperations with a focus onregulatoryand Quality Solutions.

• Trackwiseexperienceisrequired.

• Proven experience withRegulatory & Quality Systems.

• Proficient in system configurationSLAManagementandbusiness stakeholder management.

• Strong understanding of data management and regulatory requirements ( 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 communicationand teamwork abilities with experience collaborating across functional teams.

• Experience with cloud servicesandtechnologies is a plus.

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

Education/Qualifications

• AMasters /Bachelors degree in business information technology ora relatedfield. Advanced degrees or certifications are a plus.

• Itil4 Prince2 orGMPis a plus

Travel Requirements

• Positioninvolvestravel up to10% of the time mostly within Europe Asia Pacific trips will include overnight travel.

Languages

• English

• Spanish or Portuguese is a plus

Workingconditions

• Hybrid workingmodel asConvatechas a flexible approach to office working.

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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.

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