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You will be updated with latest job alerts via emailThe Solution Owner Product Lifecycle Manager (Regulatory & Quality) oversees the full lifecycle of management systems 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.
PLM Teamcentre experience is ; Compliance Wire and Polarion would be an advantage.
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 / Bachelors 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
Portuguese or Spanish is a plus
Working Conditions
Remote working model
Our transformation will change your career. For good. Youll be pushed to think bigger and aim for excellence. Your ideas will be heard and youll be supported to bring them to life. Therell be challenges. But stretch yourself and embrace the opportunities and you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work thatll move you.
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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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Required Experience:
Manager
Full-Time