QA Validation Supervisor

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY

The QA Supervisor – Validation is a member of the Quality Assurance department and partners with other members of QA, Operations, QC and Validation to work and perform an array of defined QA validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. The QA Supervisor works with internal and external project teams on validation/qualification projects, process and equipment validation, and system initiatives to ensure on time deliverables are met. The role builds upon experience gained in previous roles working on QA Validation/Validation teams. The position will lead a team of 2-4 QA Specialists – Validation.

JOB DUTIES
• Responsible for quality oversight and administration of legacy PCI QA-Validation.
• Review and approve Validation plans, User Requirement Specifications (URS), Validation protocols and summary reports, associated with the commissioning and validation of equipment and utilities, cleaning validation, process validation and method validations without supervision.
• Work in partnership with other QA and Validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, and project management to achieve all project deliverables, and build strong working relationships.
• Works closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements across all PCI sites.
• Provide QA oversight for GMP validation activities and apply risk based methodology to validation efforts.
• Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system.
• Provides guidance/mentoring to junior members of QA team on less complex issues
• Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs.
• May support cGMP manufacturing operations as needed with review of batch records and supporting documentation (Deviations, Investigations, Environmental Monitoring, and Sterilization records).
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practice.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management.
• Manage assigned QA staff, providing feedback and development to enhance team capability. Provide training on department specific procedures and systems.
• Partner with QA staff to ensure site readiness for regulatory inspections. Assist with internal audits and supplier audits as needed.
• Interface with clients as needed to address any documentation and compliance concerns.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this
classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel
so classified.

PROFESSIONAL SKILLS
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy
• Ability to make risk based decisions and resolve issues with minimal guidance
• Excellent verbal, written and interpersonal communication skills
• Effective time management and interpersonal skills.
• Strong organizational skills, planning skills and must work effectively within teams
• Well versed and proficient with all Microsoft tools in particular Word, Excel, Visio, and PPT
• Proficiency in MS Office including Word, Excel, Access and Visio

EXPERIENCE
• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/ manufacturing/quality environments.
• Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Validation experience with the following is preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Steam Sterilization, Pharmaceutical/Device Manufacturing.
• Demonstrates in-depth knowledge of QA principles, concepts, indus