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ROLE SUMMARY:

• Lead as a player/coach the group of Oncology Quality Risk Management Leads and entire POD team as needed.

• Responsible for ensuring oversight of quality risk management activities for the Oncology portfolio and Pfizer QMS by building and managing a quality risk framework that establishes a regular review of quality risk metrics and enables the right culture that proactively identifies and manages quality risk.

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

• Ensure thoughtful and timely implementation of Quality priorities by representing POD at key meetings and overseeing cross-functional POD projects.

ROLE RESPONSIBILITIES:

Quality Risk Management within Oncology Portfolio:

• Business ownership of the Oncology risk management framework, tools, technology, and processes.

• Maintaining visibility into enterprise-wide quality risks and signaling/flagging from various dashboards, and using this visibility to escalate risks to leadership

• Continuously improving risk-related technology and processes, specifically management reporting, information flow, business processes, and organizational planning, in support of Oncology quality.

• Aligning with Pfizer Research & Development (PRD) Quality for division of quality risk support responsibilities

• Drive consistent development of risk plans across studies in the Oncology portfolio; identify high-priority risks and risk trends to quality and provide expert consultation on risk management strategies.

• 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 Quality Risk Management Oversight:

• Serve as escalation point for Oncology quality risk management leads.

• Represent Quality Risk Management at Pfizer Oncology Division level meetings.

• Represent Pfizer Oncology 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 and across the Pfizer QMS. 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 risk communication within Pfizer Oncology Division, including content and structure of leadership updates.

• Develop and present quality risk point of view at Pfizer Oncology Division governance meetings.

• Advise Oncology Quality Risk Management Leads, Oncology Vendor Management Leads, and Oncology Asset Quality Leads on appropriate escalation pathways for quality risk concerns.

• Escalate/communicate quality risks to:

• Pfizer Oncology Division and PRD Quality Teams

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

• IPLT /Process Quality Leads for process level issues

• Advocate for Oncology Quality Risk Management team's continuous improvement feedback on business processes to BPOs

• Work with PRD Quality for risk-related audit and inspection preparation.

Business Development:

• Partner with Pfizer Oncology Division 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.

• Identify and, as needed, develop and maintain resources and applications supporting QRM activities.

Line Management:

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

• Guide direct reports on relevant experiences to meet career objectives.

• Oversee contractors and cross-functional teams to ensure rapid implementation of POD priorities.

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 risk 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.

• Strong experience using standard applications supporting Quality activities (e.g., Quality Management System, Risk Management System, Audit Management System).

• 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.

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

PREFERRED QUALIFICATIONS:

• Experience with Program Management best practices.

• 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.

ORGANIZATIONAL RELATIONSHIPS:

• Within Oncology CD&O: Global Study and Site Operations GSSO, Oncology Clinical Operations

• Within Pfizer Oncology R&D: Early Development, Regulatory Strategy

• Beyond Pfizer Oncology R&D: PRD GCP Quality, Regulatory QA, Global Biometrics & Data Management and Business Process Owners

Other Job Details:

• This is a people manager role

• Last date to apply is July 2, 2024

The annual base salary for this position ranges from $191,300.00 to $318,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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