Location: New York,NY, USA
Job overview:
The Director, Validation Engineering will play a crucial role in leading the management and validation of GxP-related systems to ensure compliance with regulatory standards. This role requires a strong leader with excellent communication skills, capable of prioritising and managing multiple projects effectively. The successful candidate will be responsible for ensuring the highest standards of quality and compliance across our operations.
Location: Remote/Hybrid in the United Kingdom (preference for London) or on the East Coast, USA.
Report to: Vice President, IT.
Roles and responsibilities
(include but are not limited to):
Leadership and Project Management:
* Act as IT Business Partner to the Quality, Clinical, and Regulatory functions, as needed, to provide support for applications, maintain compliance within Compass policies and procedures, establish necessary service offerings, and roadmap budget for future capabilities
* Take on the lead role in dealing with functional vendors/service providers, validation resources and associated contracts
* Take a hands-on, high-communication approach to prioritise enterprise and operational projects
* Identify resource and budget issues and collaborate with IT project managers to adjust projects based on company goals and IT budget constraints
* Participate in the development and establishment of IT PMO procedures, dashboards, and reports
* Provide clear recommendations to key stakeholders based on thorough analysis and best practice
Compliance and Risk Management:
* Run a portfolio of compliance-related IT projects focused on maturing IT's Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness
* Take ownership of, and manage the portfolio of GxP-related systems, ensuring their continued validated states
* Perform retrospective compliance risk assessments on existing IT application and system portfolio, plan and execute any GxP qualification or validation required
* Work with Business Partners and service providers to create necessary SOPs, policies and work instructions (WI)
* Manage Configuration and Change Management, Periodic Review, Audit Trail and Access review, Periodic Restore, and Vendor Management processes for regulated systems
* Represent the company's IT department during FDA Pre-Approval Inspections (PAI) and other regulatory audits
Candidate Profile:
* Bachelor's degree in IT, Engineering, Computer Science, or a related field
* Extensive experience in validation engineering within the biotechnology or pharmaceutical industry
* Proven track record of leading and managing IT projects and teams
* In-depth knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management
* Strong problem-solving skills and the ability to adapt to changing priorities and deadlines
* Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
* Aligned with our company mission and values of Compassionate, Bold, Rigorous and Inclusive