Manager Quality CQV

Responsibilities

• Ownership and management of the overall site validation strategy, rationale, and approach.
• Management of all activities within the scope of the Site Validation master Plan and maintenance of the Site Validation Master Plan, including oversight and approval of qualification activities and documents, including approval of qualification protocols, within the scope of the subordinate validation processes: Facility, Utility, and Equipment Commissioning and Qualification; Sterilization Validation; Aseptic Process Simulation/Media Fill Validation; Manufacturing Process Validation/PPQ Validation; Cleaning Validation; Analytical Method Validation; Computer System Validation; Environmental Monitoring Program.
• Coordination, management, and oversight of the process validation life cycle process for existing products and for new product introduction projects.
• Coordination of schedule, resources, activities, and deliverable requirements with Project Management, Engineering, MS&T, and Operations for the design, delivery, commissioning, and qualification of facility, utility, and equipment systems as part of new product introductions.
• Coordination of schedule, resources, activities, and deliverable requirements with MS&T and Operations for continued process verification of existing, validated processes.
• Oversight and management of the QA Sterilization Validation group.
• Oversight and management of validation consultants and contractors, where applicable, in support of activities within the scope of the Site Validation Master Plan.
• Ownership, management, and oversight of site GMP training and championing of site GMP culture, including implementation of science-based and risk-based principles, approaches, and decision-making for site CQV processes.
• Participation in change management, deviations, root cause investigations, and other impact assessments to determine impact to and corrective/preventive actions for qualified systems and validated processes.
• Representation of the site CQV program as part of regulatory inspections, client audits, and related activities.

Required Knowledge, Skills and Abilities

• Experience with the commissioning, qualification, and validation activities and processes within the scope of the Site Validation Master Plan.
• Ability to delegate responsibilities and to coordinate activities and responsibilities with other functional areas.
• Ability to manage direct reports and to coordinate and manage cross-functional teams.
• Ability to analyze and interpret validation test data to determine if processes or systems have met acceptance criteria.
• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Leadership Skills: Proven ability to influence others and lead significant change.
• Strong communication skills both written and verbal, including technical writing.
• Ability to work on multiple projects simultaneously.
• Proven experience of managing compliance to GMP regulations and guidance. Current working knowledge of cGMPs and an understanding of cleanroom manufacturing environments and related equipment.
• Ability to work consistently and compliantly, following standard operating procedures and quality policies.
• Able to review and approve GMP documentation to a high standard and relating to validation including SOPs, protocols, and reports.

Required Education and Experience

• Bachelor’s Degree (BA or BS) in engineering, science, or other, related technical discipline.
• 6 – 10 years of experience in an FDA or other GMP-regulated environment required.
• 6 – 10 years of experience working in the pharmaceutical industry preferred.
• 3 – 5 years of supervisory experience managing direct reports and/or managing teams of 5 – 10 people preferred.
• Experience working in aseptic manufacturing/cleanrooms preferred.