Itqa Business Partner

At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility.

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 as ITQA Business Partner and you’ll do the same.

**Responsibilities**: -**
Computer System Validation:

Maintain strong collaboration and alignment with business units and IT department in ensuring GxP requirements, internal and external requirements, for ensuring patient safety and product compliance at ConvaTec.
- Manage the Computer System Validation program to ensure that a consistent latest CSV/ CSA approach for IT infrastructure, R&D systems, Manufacturing systems, Quality Systems, IT tools that supports SiMD and SAMD (Softwarer is/as Medical Devices), Computerized Process Equipment, and Laboratory equipment/ systems.
- Partner with IT team and IT Business Partners to drive development, expansion, and improvement of lean practices (tools, templates, standards, work instructions) for IT systems validation, lifecycle control, and data integrity for new and existing systems to comply with ConvaTec’s policies and procedures
- Lead the lab remediation program to complete the remediation of lab equipment software in various labs
- Partner with IT Compliance team in developing, updating and publishing corporate SOPs, Templates and Work Instructions
- Perform risk analysis for product software and non-product software to determine required validation
- Provide guidance in validation of Software as a Service (SaaS) systems
- Ensure computerized systems meet applicable Data Integrity standards
- Estimate validation budget for each GxP system implementation and provide resources to the project team
- Ensure the delivery of CSV activities, tasks and deliverables as part of a project
- Facilitate and address issues and risks within a project related to Computer System Validation
- Communicates status, risks, issues and mitigation plans to stakeholders and senior leadership
- Manage onshore and offshore validation contractors
- Provide training on Computer System Validation as necessary
- Support internal and external audits

IT Business Partner for Laboratories:
Act as IT primary point of contact for R&D and QC laboratories

Ensure the delivery of IT road map for lab systems such as SDMS, ELN and LIMS

Manage IT technical resources supporting lab systems

Communicate IT initiatives, decisions, priorities and relevant information to Business counter parts

Work with IT and Business to improve the IT support process for laboratories

Partner with Business Leadership to define opportunities and identify and prioritize projects based on business need, ROI, productivity and compliance

**Qualifications**:

- Bachelor’s degree in Engineering, Pharmaceuticals, Science and related field
- 10+ years of relevant experience in Computer System Validation in life sciences industry (Pharmaceutical, Medical Devices, Biotechnology)
- 10+ years of experience in executing CSV projects for IT systems
- Excellent working knowledge of 21 CFR Part 820, GAMP 5, 21 CFR Part 11, Annex 11, GDPR and Data Integrity
- Experience working with global project teams
- Experience in Laboratory systems such as lab equipment software, Empower 3, SDMS, ELN and LIMS
- Experience in validation of enterprise systems such as SAP Enterprise Resource Planning (ERP), TrackWise Quality Management System (QMS), Veeva Clinical, Product Lifecycle Management (PLM), Calibration Management, and Manufacturing Execution Systems (MES)
- Proven record in successful collaborations with multiple teams and departments in delivering CSV
- Ability to resolve issues, conflicts and differences of opinions related to Computer System Validation
- Ability to analyze the risk on each situation and propose compliant solution to project teams
- Excellent verbal and written communication skills
- Ability to work independently with mínimal direction
- Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills

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.