Director, Quality Management Systems/Validation & Compliance Lead

ROLE SUMMARY

The QMS/V&C Lead is responsible for driving GWE R&D Compliance Program and Systems across Global sites.  The incumbent will oversee, manage, and assure overall adherence to the Compliance Program for GWE R&D and drive GWE’s Continuous Improvement approach to service, customer and compliance assurance.

The QMS/V&C Lead supports GWE R&D by driving strategy, compliance requirements, control, quality, and continuous improvements. In the Compliance area, the Director provides strategy, management advice, ownership, and guidance to all applicable GWE R&D functions by identifying short-term and long-term strategy, daily interpretation, and application of compliance requirements for services managed by GWE R&D.  In addition, the Director is responsible for assuring compliance with corporate policies for GWE R&D.  Lead the design, deployment, training, and subsequent continuous improvement of applicable global functional elements of the Compliance Program.  Be responsible to direct the management of compliance functions (e.g., validation, documentation, and training) in support of cGLPs, cGCPs, cGMPs as well as other non-EHS regulatory regulations. The position will work in conjunction with GWE colleagues, contractors, R&D business units, R&D research units, and vendor resources to manage initiatives and assure regulatory compliance.

ROLE RESPONSIBILITIES

The major duties and responsibilities for QMS/V&C will include but are not limited to:

• Assures compliance for all site facility cGLP, cGCP, cGMP and other non-EHS compliance systems and activities
• Budget responsibility for compliance functions
• Oversees adherence to the GWE R&D document management strategy
• Develops, manages, and reports progress to GWE R&D Leaders against the GWE Compliance Program and progress on implementation, gap closure, and strategy
• Develops overall area program documentation and ensures documentation compliance
• Plans, leads, and participates in management system audits, including the preparation of review report and identification of corrective actions and follow through
• Verifies corrective action requests, monitors evaluation of responses, and determines if identified corrective action successfully resolves intent of findings/issues
• Monitors and drives completion of quality review corrective actions
• Engages site stakeholders including GWE colleagues, strategic partners, vendors and customers and other resources in the development of the area Compliance program
• Ensures the consistent application of and adherence to the Compliance Program across all GWE R&D area functions
• Ensures the GWE R&D area Compliance Program compliments existing PRD and ORD programs
• Monitors the overall Compliance Program effectiveness and identifies and implements changes based on efficiencies/changing business needs
• Identifies and leads area certification/registration efforts for the GWE R&D compliance
• Facilitates GWE R&D SME team meetings in the development of short-term and long-term strategies and policies for applicable functional elements of the GWE R&D Compliance Program
• Global contact for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance Program
• Global point of contact for interpretation of all functional elements of the GWE R&D Compliance Program 
• Facilitates development of annual GWE R&D compliance related objectives and goals
• Conducts Site Risk Management Reviews and reports on the status and recommend areas of improvement to GWE R&D leadership
• Issues, maintains, and controls all site-level compliance system procedures and related documents
• Provides guidance and feedback to site functional representatives regarding strategy, policy, and documentation activities
• Facilitates the development of new approaches to solve site management system and business issues
• Prepares comprehensive status reports and presentations for GWE R&D Site Leaders, GWE R&D Leader
• Liaises with third party assessors in the site assessment of the department’s Quality Management System
• Ensures appropriate correspondence with all internal and external area customers on any Management system-related matters.

BASIC QUALIFICATIONS

• Bachelor’s Degree in relevant discipline and 8+ years of relevant work experience.

PREFERRED QUALIFICATIONS

• Master's Degree in relevant discipline
• 15 year’s experience in facility management, engineering, or compliance related area of pharmaceutical business