Senior Director, Oncology Category Quality Lead

ROLE SUMMARY:

Lead as a player/coach the group of Asset Quality Leaders and accountable for the management and oversight of GCP performance and quality systems within the oncology portfolio.

Responsible for ensuring Level 1 GCP quality for clinical development programs within Pfizer Oncology R&D by establishing a quality framework that drives the creation and management of mitigation plans, establishes a regular review of GCP quality metrics and enables the right culture that incentivizes teams to meet Pfizer Quality Standards.

Work closely with the Quality team within Pharmaceutical Research and Development (PRD) and other Pfizer teams as required to ensure alignment of Quality frameworks, governance, and operational support.

ROLE RESPONSIBILITIES:

Quality Planning within Oncology Portfolio:

Define optimal resourcing strategy and GCP quality support within Oncology Portfolio, aligning with PRD Quality for division of quality support responsibilities aligned to Pfizer’s hub and spoke operational model.

Drive consistent development of risk plans across studies in the Oncology portfolio; identify high-priority risks to quality and prospectively implement appropriate mitigation plans.

Influence development of new risks and evolving existing risks in relevant Quality Risk Management (QRM) tools.

Provide feedback to QRM Business Process Owner (BPO) to continuously improve Integrated Quality Management Plan (IQMP) approach and other QRM process-related activities.

Oncology Portfolio Quality Oversight:

Oversee GCP quality of oncology portfolio and serve as point of escalation for GCP quality accountability within Pfizer Oncology R&D

Represent Portfolio Quality Management at Pfizer Oncology R&D level meetings.

Represent Pfizer Oncology R&D Quality at PRD Quality functional level and Enterprise leadership meetings.

Ensure analysis and interpretation of quality data from multiple sources to identify key issues/risks at the portfolio level. Communicate knowledge/trend information to relevant quality and portfolio governance committees.

Maintain line-of-sight into quality risks and issues across oncology portfolio.

Escalation, Communication, and Governance:

Set strategic framework for quality communication within Pfizer Oncology R&D, including content and structure of leadership updates.

Develop and present quality point of view at Pfizer Oncology R&D governance meetings.

Advise asset/study team on appropriate escalation pathways for quality concerns.

Escalate/communicate quality issues to:

Pfizer Oncology R&D and PRD Quality Teams

Governance committees (e.g., GCP QOC, RDM QCC)

IPLT /Process Quality Leads for process level issues

Advocate for study teams’ continuous improvement feedback on business processes to BPOs

Communicate key quality information (e.g., inspection/audit learnings) across asset/study teams and serve as asset quality expert.

Work with PRD Quality for audit and inspection preparation, and management of CAPAs.

Business Development:

GCP quality representative of the Pfizer Oncology R&D due diligence team for business development opportunities#.

Partner with Pfizer Oncology R&D and PRD leaders and cross-organization Quality leaders to assess development program strategy and key quality risks to inform the assessment of opportunities for oncology.

Drive identification of key quality risks and proposed mitigations related to acquisitions and incorporate into study level risk planning.

Provide strategic input to risk-based quality approaches.

Line Management:

Leads and manages performance for an assigned group of Asset Quality Lead direct reports through goal setting, ongoing assessment, and coaching.

Guide direct reports on relevant experiences to meet career objectives.

Determine program assignments within Oncology portfolio.

BASIC QUALIFICATIONS:

A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:

Bachelors – 15+ years or equivalent

MS/MBA – 13+ years or equivalent

PhD/PharmD/MD – 10+ years or equivalent

Ability to build strong network/knowledge/relationships with internal/external stakeholders.

Advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.

Familiarity with the oncology therapeutic area.

Advanced clinical trials experience, especially operational processes and/or systems.

Leadership and people management as part of a matrix organization.

PREFERRED QUALIFICATIONS:

Skilled in project management.

Strong interpersonal skills, ability to influence, and ability to build and maintain excellent working relationships across lines in a matrix organization.

Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.

Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.

Ability to implement strategies using coordinated and transparent metrics to track and manage compliance.

Spotfire and Excel skills/experience.

Other Job Details:

Work Location: On Premise / Hybrid

This is a people manager role

Last date to apply is June 9, 2024

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

---