Pfizer Oncology Third Party Quality Lead

ROLE SUMMARY

• Reporting into the Head of Oncology Quality, the T hird Party Quality Lead is the point person for third party oversight across indications, working with stakeholders and relevant oversight teams for third party quality risk management, issues management and general Good Clinical Practice guidance.
• Establish and maintains Quality-to-Quality contacts with major vendors and site entities partnering with Oncology Clinical Development & Operations (CD&O).
• Responsible for assessing and ensuring that clinical trial, research and other Pfizer Oncology R&D third party vendors have the appropriate quality systems infrastructure, including a culture of quality and compliance to adhere to Pfizer Oncology’ s policies and procedures with all applicable external regulatory requirements relating to GxP including those related to patient safety, data integrity, and protocol adherence as set out in the vendors Master Services Agreement.
• Supports development and implementation of the vendor engagement framework, including processes, tools, roles and sourcing strategy.
• 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 .
• Work s closely with PRD Transformation Office, Pfizer Oncology R&D’s Oncology Unit M anagem ent Office and other R&D departments to ensure an effective selection and oversight process is in place for internal functions, vendors, service providers, and Contract Research Organizations (CROs).

ROLE RESPONSIBILITIES

Third Party Quality Framework

• Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings.
• Educate and support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements.
• Ensure appropriate quality agreements, standards and specifications are established and maintained where required .
• Evaluate quality performance at an enterprise level to inform continuous improvement of quality risk management.
• Provide QA leadership for internal function, vendor, service provider, and CRO issue management and escalation process.
• Assist in the development and implementation of strategic procedures and work practices to ensure continuous quality improvement.
• Maintain and build effective relationships with key internal and external stakeholders to support third party maintenance.
• Develop and communicate internal process and vendor risk assessments and risk mitigation to senior management.
• Conduct third party risk assessments, risk mitigation planning, and monitoring.

Vendor Quality Management

• Identify , evaluate and respond to GCP quality risks related to vendor and site engagement.

• Interact with internal departments and CROs to address compliance and quality issues.

• Strategically utilize quality and compliance data (e.g., KPIs, QTLs, milestones) to monitor the vendor, service provider, and CRO portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues, and general quality state. Analyze and interpret data from multiple sources to drive quality assessments.

• Identify high priority risks to quality/compliance and prospectively implement mitigation plans.

• Validate , monitor and close out GCP-quality-related action plans.

• Provide quality oversight reports to appropriate Pfizer Oncology management / functions.

• Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties.

• Informs site organization relationship owner of quality improvement considerations.

• Support in the development and implementation of process updates

• Work with technical writers to help develop, review, and revise SOPs for GCP/GLP/GVP QA processes.

• Assess and evaluate internal function and vendor changes from a quality perspective.

Vendor Audit / Inspection Support

Conduct Risk Assessments, Risk mitigation planning, and monitoring to define the internal and vendor audit program. Lead internal and external audits.

• Arrange global GCP/GLP/GVP internal audit, vendor, service provider, and CRO auditing program/calendar, balance workload, and arrange contract audit support when needed.

• Conduct effectiveness checks to verify the CAPA outcome.

• Incorporate risk, regulatory intelligence, QMS, and other key data into audit program definition activities .

• Maintain and manage audit schedule.

• Perform routine onsite audits/evaluations at vendors and CRO facilities.

• Manage others performance in a matrixed environment (e.g., contract auditors, co-auditors)

• Minimum B achelor of S cience with 1 4 + years or equivalent experience supporting EU and FDA GCP, GLP, and GVP functions.
• Preferred MS/MBA with 12+ years or equivalent experience supporting EU and FDA GCP, GLP, and GVP functions.
• Advanced knowledge in Phase I-IV clinical trial operations and the related regulations/guidelines.
• Quality related experience including working knowledge in:

• Oncology GxP experiences for application across vendor types.
• Quality and compliance management, QC.
• Root Cause Analysis.
• Risk identification, controls, mitigations, and actions.
• Metrics development and utilization.
• Audit and Inspection conduct and CAPA response process.

• Ability to implement strategies using coordinated and transparent metrics to track and manage compliance.
• Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.
• Able to navigate matrix organizations and influence without formal authority to drive collaboration and build trusted partnerships with clinical study teams and leadership.

• Experience in planning, conducting and reporting of audits.
• Experience in working with GCP vendors.
• Experience developing SOPs, reviewing internal drug safety, clinical operations, regulatory and medical processes to ensure they are accurately represented in current SOPs.
• Must have excellent communication skills (verbal and written).
• Highly organized with strong attention to detail, clarity, accuracy, and conciseness.
• Experienced Quality Professional with significant GCP, GLP, and GVP internal process auditing and supplier relationship management experience.

#LI-PFE

The annual base salary for this position ranges from $144,900.00 to $241,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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 tendersglobal.net (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

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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