Director, Quality Management Systems/Validation & Compliance Lead

Job description

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 First class interpersonal skills required to develop effective relationships at all levels throughout the business Proven financial management and analytical skills to ensure the cost-effective provision of business services across Pfizer Able to translate customer needs into action and meet needs of customer Able to ensure business continuity and develop appropriate business contingencies Able to create and implement strategy in own work area Able to create an environment in which Pfizer core values are valued through leading by example in these values Can advise and influence senior management and colleagues to ensure high performance Responsible for developing and training of staff in own work area to maintain best caliber individuals MINIMUM KNOWLEDGE: Detailed understanding of Facilities Management marketplace, particularly delivery of hard and soft services Proven financial management experience Have track record of sustaining effective relationships with customers, and external and internal service providers Proven experience of bottom line focus and able to implement in own work area to demonstrate costs savings and efficiencies Track record with experience at senior level Able to demonstrate a professional career and subject matter expertise within Facility Management and Quality Management Systems Experience of managing multi-disciplinary teams Need to demonstrate the ability to perform a highly professional role Ability to develop services and implement new policies and strategies Proven knowledge/prior experience implementing and managing and maintaining quality systems (e.g., ISO 9000, Malcolm Baldrige, etc.); technical records and six sigma experience a plus Demonstrated thorough understanding of GLPs, GCPs and GMPs High level of leadership capability and credibility, and ability to influence Skilled at team facilitation to build consensus and reach decisions Strong, effective, and proactive communicator particularly across global sites and customers Knowledge of GWE business functions and/or pharmaceutical R&D line knowledge Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Due to the nature of work assignments, incumbents must be able to perform detailed work on multiple, concurrent tasks, with frequent interruptions and under time constraints. On a daily basis, the position responsibilities may require the ability to stoop; to reach; to stand, to walk the site for extended periods of time; to push and/or pull objects weighing up to 30 pounds; to lift and carry objects weighing up to 15 pounds; to use finger dexterity to operate a computer and other office equipment and hand strength to grasp objects; to perceive the attributes of objects by touch; to hear and verbally exchange ideas and information with colleagues and others on the phone and in the office; to see clearly from less than one foot to arm’s length with a good field of vision and to distinguish basic colors and shades of color. On a frequent basis, essential duties of the position may require the ability to climb stairs, to kneel and/or crouch to retrieve items. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS · Day shift with occasional after hours or weekend response required · Periodic travel m