Director, Quality Management Systems/Validation & Compliance Lead
$162,900–$271,500 year
On-siteGroton, Connecticut, United States or Andover, Massachusetts, United States
Job Summary
Lead the design, deployment, and continuous improvement of global Quality Management Systems and validation compliance for GWE R&D. Manage adherence to cGLP, cGCP, and cGMP regulations across all site facilities while overseeing budget responsibility for compliance functions. Direct management system audits, verify corrective actions, and facilitate stakeholder meetings to develop short-term and long-term strategies. Serve as the global point of contact for interpreting compliance requirements and ensuring documentation alignment with corporate policies. Prepare comprehensive status reports for R&D leadership and liaise with third-party assessors during site evaluations. Conduct Site Risk Management Reviews and drive efficiency initiatives to optimize the overall compliance program.
Required Qualifications
- Bachelor's Degree in relevant discipline
- 8+ years of relevant work experience
- 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
- Able 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
- 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
- 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
- Entry and work in laboratory spaces, GxP aseptic space, mechanical/electrical rooms, Central Utility Plant, services areas such as maintenance shops, shipping and receiving, service corridors with adherence to personal protective equipment practices and procedures as well as aseptic gowning and procedures
- Candidates must be authorized to be employed in the U.S. by any employer
- U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future
- This position requires permanent work authorization in the United States
Desired 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
- 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
- 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
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