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Sr Director PCRU Quality Group Lead

Company: Pfizer
Location: New Haven
Posted on: September 12, 2020

Job Description:

ROLE SUMMARY

The Pfizer Clinical Research Unit (PCRU) Quality Group Lead is the single point of accountability for the strategic direction and leadership of ongoing operations of the global quality framework of the PCRUs. This quality framework will set the stage for an overall quality culture and encompass robust SOP and training.

This role provides leadership and drives the strategy for the activities related to Quality, Inspection Readiness, and Audit Response management for the PCRUs globally and will serve as a point of escalation for quality issues arising within the PCRUs.

This role also has overall accountability to lead the development and harmonization of the PCRU SOP and Training Program, in collaboration with PCRU sites leadership, including the implementation of both global and local procedures and the associated end to end training and ongoing learning needs of the PCRUs.

The individual will sit as part of the PCRU Leadership team and provide the global strategy and oversight of the PCRU QMS & GCP Quality Performance function to proactively mitigate GCP risk, and control and improve end-to-end process, study, and site quality. This position will be fully accountable for the Quality Risk Management Process, including the associated tools and resources, and will be accountable for ensuring adherence to emerging global GCP Requirements in his/her area of responsibility.

The individual will also provide the global strategy, oversight and business performance for the Global PCRU quality framework.

ROLE RESPONSIBILITIES

Inspection Readiness

Ensures the PCRU inspection readiness is maintained for all PCRU activities globally, including the global strategy for PCRU SOP development, maintenance, and training as well as defining and delivering the process, approach and training for the inspection readiness program.

Identifies and communicates risks relative to PCRU’s sites inspection readiness.

Supports inspection activities, as lead by the RQA IM team, by leading the PCRU Quality Compliance Managers and others at the PCRUs. He or she will proactively coordinate with stakeholders as necessary, prepare and review documents/storyboards in addition to prepping individuals and groups as necessary.

Ensures the development of PCRU responses to inspection findings, the conduct of project-level mock inspections, and the communication of the inspection progress and outcomes as necessary.

Ensuring the lessons learned activities are performed and communicated.

Audit Response Management :

The PCRU Quality Lead will be the primary point of contact for Corporate Audit, CD&O Operations, Clinical and vendors for GCP-related process PCRU audits. This individual will ensure input to the audit plans, coordination of audit responses with the BPOs and senior management, facilitation of the development of the responses to the audit findings and ensure audit CAPAs are effective and completed and documented in accordance with the agreed timelines.

GCP Quality Risk Management Planning and Mitigation:

Sets the vision for GCP quality risk management at the PCRUs globally

Leverage GCP quality experience and external site operations knowledge and expertise across the Portfolio and Vendor Quality groups to enhance approach, methodology, and tools to improve portfolio, process and site quality risk management

Identifies and ensures adherence strategy to emerging global GCP guidelines

SOP and Training:

Responsible for leading the development of, and driving processes to ensure, efficient and timely maintenance of PCRU SOPs and associated training that is consistent with the needs of the PCRU business and the enterprise framework.

Quality Culture:

Develop and implement PCRU cultural programs to strengthen understanding of GCP QMS and ensure a stronger connection to that of global Pfizer

Interact with PCRU leadership to reinforce their role in ensuring a robust quality culture

Oversight:

Evaluate PCRU compliance to the QMS and operational CMCDs; work with PCRU leadership and team to mitigate/remediate gaps

Drive CAPA creation and remediation of quality issues

Develop KPIs for quality performance for PCRU study and site

Develop a strategy for continuous process improvement based on performance and quality trends

Interact with PCRU staff to understand issues and concerns that are impacting compliance and culture

BASIC QUALIFICATIONS

BS– 13 years of experience, MS – 10 years, PhD/MD – 8 years of experience with quality as a function, quality assurance, quality compliance, risk management, quality investigations and associated clinical and preventive action development, and inspection readiness activities.,

Six to eight years of leading complex cross functional teams as well as people management experience.

Broad based experience in clinical pharmacology and exploratory clinical research, and an in-depth knowledge of Good Clinical Practices.

Leadership, project/resource management (project, staff, finances), administrative, and technical capabilities are required.

PREFERRED QUALIFICATIONS

Communication - Superior verbal and writing skills. Ability to communicate effectively and appropriately with internal and external stakeholders both internally and externally.

Teamwork - Ability to work independently and within a team; shows respect and support for all team members. Works collaboratively with group members and contributes to positive intra- and inter-team relationships both locally and globallyExceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict.

Well-developed strategic planning, observation, analytical operational execution and problem-solving skills.

Demonstrated knowledge of clinical pharmacology and exploratory clinical research processes and regulatory requirements.

Preferred experience of directly managing a team with direct accountability for performance/or with a direct customer relationship responsibility.

Demonstrated ability to manage complex projects and cross-functional processes required.

Demonstrated platform skills; experience presenting to large non-science populations.

Other Job Details:

Last Date to Apply for Job: September 7, 2020

Additional Location Information: Belgium, Brussels, Groton, CT, New Haven, CT

Eligible for Relocation Package

#LI-PFE

Eligible for Employee Referral Bonus

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.

Quality Assurance and Control

Posted 2 Days Ago

Full time

4791713

About Us Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, New Haven , Sr Director PCRU Quality Group Lead, Other , New Haven, Connecticut

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