Quality Validation Manager

About the role

Kelly Science is seeking a Quality Assurance Validation Lead to join a growing team located in Raleigh, NC. Salary: $135,000/year Shift: Monday-Friday 1st Shift (Fully on-site) Employment Type: Full Time; Direct Hire Summary Of Position Lead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations. Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes. Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies.

Responsibilities

• Lead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations.
• Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts.
• Manage the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes.
• Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies.
• Perform and document risk assessments of systems and processes, assess change proposals, draft/review/approve protocols, and reports, evaluate deviations/change controls and initiate revisions of GMP documentation related to validation.
• Provide leadership on the activities of the internal validation staff as well as external validation contractors.
• Establish priorities to ensure that deadlines are met, and budgets are not exceeded.
• Create, coordinate, maintain and enforce Validation systems, policies, and procedures.
• Participate in audits and inspections conducted by internal and external entities.
• Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes.
• Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
• Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.
• Manage the revalidation program.
• Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.
• Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.
• Write and review policies or procedures for compliance with regulatory guidance.
• Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.
• Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.
• Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.
• Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.
• Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.
• Direct supervision of contractors or other specialists.

Requirements

• Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning, and Process Validations.
• Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.
• Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
• Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and performance reviews).
• Strong coaching and mentoring skills and a track record of developing direct reports.
• Identify quality issues, and in conjunction with site Quality Manager, recommend and implement corrective and preventative actions.
• Good communication with multiple individuals, departments, contractors, auditors and strong organizational skills.
• Knowledge of cGMP, cGLP, cGXP, FDA, ICH, EMEA and 21 CFR 11 regulations, guidelines, policies and procedures for parenteral/injectable products.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
• Knowledge of agency and vendor audits.
• Able to respond/react with appropriate urgency/ professionalism and make decision under pressure.
• Support goals and initiatives tied to Guerbet Plan and department goals.
• Evaluate current systems and process to determine upgrades, additional technology and improve as needed.
• Support document approval for URS, DQ, Protocol {IQ, OQ, PQ, PPQ}, validation batch records, change request, Risk Assessments, Reports, Test plans/ Transfers, laboratory documents/ Testing and SOPs.