About the Role
This position plays a vital role in ensuring compliance with regulatory requirements, particularly in IT and Operational Technology.
The successful candidate will be responsible for managing regulatory compliance programs, focusing on computer systems validation and compliance activities. They will also collaborate with various stakeholders to drive innovation and enhance productivity within the organization.
Key Responsibilities:
* Manage regulatory compliance programs, ensuring adherence to policies and procedures.
* Deliver top-quality computer systems validation for capital projects.
* Promote automation validation standards across projects.
* Collaborate with site compliance and validation teams to coordinate activities.
* Ensure compliance with relevant regulations, including Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity.
* Act as a Subject Matter Expert on computer validation for capital projects.
* Provide ongoing validation, training, and compliance support.
* Represent compliance activities to internal and external auditors.
* Assist in developing audit responses and engage with local quality organizations.
* Identify and address IT and Operational Technology compliance risks.
* Conduct risk assessments for new technologies or significant changes.
* Support local teams in navigating quality and compliance challenges.
* Report on execution challenges and adherence to procedures.
* Advocate for changes to Systems Development Lifecycle policies and procedures.
* Participate in a compliance group to share knowledge and improve execution.
Requirements:
* Bachelor's Degree in Computer Science, Engineering, Regulatory Compliance, or a related field.
* 5+ years of experience in compliance activities for capital projects.
* Strong knowledge of regulatory requirements related to computerized systems validation.
* Familiarity with ISA S95 and S88 Standards in a Good Practice environment.
* Experience validating and qualifying Cloud, Software as a Service, and data integration platforms.
* Extensive experience with automation systems and leading validation teams.
* Understanding of end-to-end manufacturing processes, including Manufacturing, Quality, and Supply Chain.
* Ability to collaborate with diverse stakeholders and manage conflicting priorities.
* Excellent written and verbal communication skills, with the ability to simplify complex concepts.
* Strategic thinker capable of navigating ambiguity and developing actionable plans.
* Self-motivated leader who can drive results with minimal direction.
Preferred Requirements:
* Postgraduate qualification in Business Strategy or IT Architecture.
* Experience in the pharmaceutical industry, particularly in Manufacturing and Supply Chain.
* Knowledge of integrating real-time shop floor and lab systems at an enterprise level.
* Familiarity with manufacturing analytics systems and business process re-engineering principles.
Travel Requirements:
* Willingness to travel 10-25% for assignments outside your primary location.