Director, Quality Management Systems/Validation & Compliance Lead

Pfizer · Andover, MA · Today

On-siteQuality Assurance$163k–$272k/yrFull-time

About the role

The QMS/V&C Lead is responsible for driving the 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, compliance assurance, and customer outcomes. The role supports GWE R&D by setting strategy, interpreting compliance requirements, and leading quality and continuous improvement initiatives. The Director provides strategic guidance, ownership, and oversight to all applicable GWE R&D functions by identifying short- and long-term strategy, daily interpretation, and application of compliance requirements for services managed by GWE R&D, and by assuring compliance with corporate policies. The position leads the design, deployment, training, and continuous improvement of global functional elements of the Compliance Program, and directs the management of compliance functions (e.g., validation, documentation, and training) in support of cGLPs, cGCPs, cGMPs, and other non-EHS regulatory regulations. The role collaborates with GWE colleagues, contractors, R&D business units, research units, and vendor resources to manage initiatives and assure regulatory compliance.

Responsibilities

Assure compliance for all site facility cGLP, cGCP, cGMP, and other non-EHS compliance systems and activities
Have budget responsibility for compliance functions
Oversee adherence to the GWE R&D document management strategy
Develop, manage, and report progress to GWE R&D Leaders against the GWE Compliance Program, including implementation, gap closure, and strategy
Develop overall area program documentation and ensure documentation compliance
Plan, lead, and participate in management system audits, including preparation of review reports and identification of corrective actions with follow-through
Verify corrective action requests, monitor evaluation of responses, and determine if identified corrective actions successfully resolve the intent of findings/issues
Monitor and drive completion of quality review corrective actions
Engage site stakeholders including GWE colleagues, strategic partners, vendors, customers, and other resources in the development of the area Compliance Program
Ensure consistent application and adherence to the Compliance Program across all GWE R&D area functions
Ensure the GWE R&D area Compliance Program complements existing PRD and ORD programs
Monitor overall Compliance Program effectiveness and identify and implement changes based on efficiencies and changing business needs
Identify and lead area certification/registration efforts for the GWE R&D compliance
Facilitate 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
Serve as global contact for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance Program
Serve as global point of contact for interpretation of all functional elements of the GWE R&D Compliance Program
Facilitate development of annual GWE R&D compliance-related objectives and goals
Conduct Site Risk Management Reviews and report status and recommend areas of improvement to GWE R&D leadership
Issue, maintain, and control all site-level compliance system procedures and related documents
Provide guidance and feedback to site functional representatives regarding strategy, policy, and documentation activities
Facilitate the development of new approaches to solve site management system and business issues
Prepare comprehensive status reports and presentations for GWE R&D Site Leaders and GWE R&D Leader
Liaise with third-party assessors in the site assessment of the department’s Quality Management System
Ensure appropriate correspondence with all internal and external area customers on any management system-related matters

Qualifications

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

Preferred Qualifications

Master’s Degree in a relevant discipline
15 years of experience in facility management, engineering, or compliance-related areas of the pharmaceutical business

Minimum Knowledge

Detailed understanding of the Facilities Management marketplace, particularly delivery of hard and soft services
Proven financial management experience
Track record of sustaining effective relationships with customers, external and internal service providers
Proven experience with bottom-line focus and ability to implement cost savings and efficiencies in own work area
Track record of experience at senior level
Demonstrated ability to perform a highly professional role
Ability to develop services and implement new policies and strategies
Proven knowledge and prior experience implementing, 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

Leadership Capabilities

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. Daily responsibilities may require the ability to stoop; reach; stand and walk the site for extended periods; push and/or pull objects up to 30 pounds; lift and carry objects up to 15 pounds; use finger dexterity to operate a computer and other office equipment and hand strength to grasp objects; perceive the attributes of objects by touch; hear and verbally exchange ideas and information with colleagues and others on the phone and in the office; see clearly from less than one foot to arm’s length with a good field of vision and distinguish basic colors and shades of color. Frequent duties may require the ability to climb stairs, kneel, and/or crouch to retrieve items.

Work Environment

Entry and work in laboratory spaces, GxP aseptic space, mechanical/electrical rooms, Central Utility Plant, service corridors, maintenance shops, shipping and receiving, with adherence to personal protective equipment practices, aseptic gowning, and procedures.

Schedule and Travel

Day shift with occasional after-hours or weekend response required
Periodic travel may be required in support of GWE business needs
Respond to the site in support of business continuity, emergency response, and off-shift schedules periodically

Pay

The annual base salary for this position ranges from $162,900.00 to $271,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in the share-based long-term incentive program.

Benefits

401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday, and personal days
Paid caregiver, parental, and medical leave
Health benefits including medical, prescription drug, dental, and vision coverage