Pfizer Process Quality Lead in Groton, Connecticut
Provides leadership in assuring that clinical trial processes, as part of Pfizer's GCP QMS, meet or exceed the requirements of Pfizer's standards and the regulatory authorities.
Responsible of a set of processes for the following areas:
Biometrics - extensive knowledge and experience in Statistical, Clinical Data Management, Analysis and Reporting, Submissions and Disclosure processes
A strategic partner for functional lines focused on applying business process management to drive quality and business outcomes that are aligned with strategic objectives.
Leads a cross-functional, cross-process team focused on process quality, process change control, and improvement of process efficiencies
Evaluates the process performance, reports on performance and oversees corrective actions
Drives the end-to-end redesign and continuous improvement of existing processes / systems / controls to ensure that quality is built-in and to enhance process performance.
Oversees the development and execution of all CAPA commitments for assigned process.
Drives process quality through the following activities:
Leading the Integrated Process Leadership Team for a set of specific process area.
Set IPLT strategy and process goals to optimize processes & ensure organizational alignment
Align domain processes with implementation of new organizational / technology constructs
Assure IPLT process performance
Develop IPLT process quality plan
Review, manage and communicate process domain performance through routine process reviews and assessments
Resolve process gaps and issues or escalate as needed through the appropriate quality governances (i.e. GCP-QOC, QCC)
Understands and ensures compliance with regulatory & process requirements and commitments
Review & endorse all process / metric changes including CMCDs/deviations
Coordinate inspection, audit and quality event process participation & manage outcomes
Report out on IPLT progress, highlighting risk areas at the Quality Center of Excellence review forums, and other quality governances as needed; collaborate with functional line leadership to mitigate risk areas and issues.
Partner with the Quality Leads in the functional areas to drive process performance and efficiencies.
Collaborate with other IPLT leads to maintain an enterprise process management focus
BS - 15 years or equivalent
MS - 10 years or equivalent
Ph.D./MD - 5 years or equivalent
Strong understanding of Biometrics - extensive knowledge and experience in Statistical or Clinical Data Management or Analysis and Reporting or Submissions and Disclosure processes
Recognized process and subject matter expertise for process areas at a senior leadership level. Ability to understand large complex processes with a focus on continuous improvement and process performance
Significant experience within Pharmaceutical or healthcare industry
Demonstrated experience engaging executive leaders and establishing stakeholder relationships
A scientific or technical degree is preferred. Business degree and/or coursework are desirable.
Experience working in a regulated environment, developing quality and compliance programs is preferred
Knowledge of process management and continuous improvement methodology (ie Lean/Six Sigma) beneficial
"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."
Other Job Details:
Additional Location Information: Global any Pfizer Site, United States - New York - New York City, United States - Pennsylvania - Collegeville
No Relocation Offered #LI-PFE
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EEO & Employment Eligibility
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Continuous Imprv and Proj Mgmt