1+ months

Process Quality Lead

Groton, CT 06340

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

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Continuous Imprv and Proj Mgmt


Posted: 2020-05-11 Expires: 2020-07-12

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Process Quality Lead

Groton, CT 06340

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