CQV Manager

JOB SUMMARY

Reporting to CQV Manager, the CQV Lead role will lead and coordinate the CQV project activities in line with the site project strategy. The CQV Lead will work cross all project functions including but not limited to process

engineering functionally across Operations, Operational Engineering, Quality Operations, EHS, Logistics, Lean & Digital to understand their functional requirements and develop and execute the optimum validation strategy.

MAIN RESPONSIBILITIES

• Accountable for the following activities (but not exclusively),
• Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
• Support and coordinate the transition to a digitized C&Q platform
• Ensure effective resource planning is established and managed throughout the project in line with schedule and associated CQV budget including the management of CQV personnel.
• Manage and coordinate equipment qualification activities, including but not limited to Factory Acceptance Testing (FAT), SAT, DQ Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
• Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
• Manage and coordinate all CQV documentation to support CQV activities
• Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
• Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
• Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols.
• Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
• Disclaimer: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed

EDUCATION/QUALIFICATIONS

• Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q platform i.e. Kneat Solutions
• Clear understanding and previous experience in deployment and execution of a RBV (Risk Based Validation) process in line with the ISPE guidelines.
• Experience of managing teams or projects in a fast paced and complex environment.
• Relevant qualification (Degree) and / or relevant experience of 10 + years in biotech / pharmaceutical industry qualifying GXP systems.
• Significant project lifecycle experience in delivering CQV projects for Capex projects.
• Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
• Excellent verbal and written communication skills, Experience in developing a strong working relationship with other departments.
• Strong analytical problem-solving skills. Dynamic decision maker, effective planner, and communicator