Head, Quality Center of Excellence & Business Development Integration Lead

ROLE SUMMARY

The Vice President, Quality Center of Excellence is responsible for the oversight of Good Clinical Practices (GCP) within the Enterprise Quality Management System, across the entire spectrum of clinical development (Phase 1 through Phase 4) and all regions including Development Japan and Development China in the Global Product Development (GPD) organizations. This role collaborates with senior leadership across Global Product Development, Worldwide Research Development Medical (WRDM), Regulatory Quality Assurance (RQA), Legal, Compliance and Corporate Audit to revolutionize delivery across the Clinical Development continuum through quality excellence, trusted partnership, and risk-focused prevention. This role will also serve as the key GRA point of contact for Business Development Integration needs.

• Responsible for maintaining an effective global quality system to ensure compliance with GCP and other applicable regulations e.g. ICH, General Data Protection Regulation (GDPR).
• Quality Event management globally for Global Product Development (GPD) and Worldwide Research and Development Medical (WRDM) GCP related events.
• GCP Quality Standards, process and QMS management.
• Drive enhanced quality oversight for priority programs.
• Oversight and management of GCP risk across the clinical development continuum
• GCP Integration Standards management and oversight.
• Audit and Inspection readiness globally for GPD.
• Quality metrics and analytics across GPD.
• Maintaining excellence in all quality clinical submissions.
• Drive GCP Quality culture.
• Drive continuous improvement and best practices across all areas of Clinical Trial Development and Submission quality.
• Drive GRA Business development activities and integration management including assessing resource demand requirements and the development of best practices for Regulatory functions
• Represent GRA in key interfaces with WRDM and other GPD lines to support business development activities

JOB RESPONSIBILITIES

• Lead the Quality Center of Expertise (COE) for GPD with accountability to assure the Good Clinical Practices (GCP) quality of clinical trial execution, ensuring quality standards, monitoring of quality performance metrics and effective deviation and CAPA management.
• Provide GCP quality oversight of vendors/Clinical Research Organizations (CROs), ensuring quality standards, monitoring of quality performance metrics and effective deviation and CAPA management.
• Chair the GCP Quality Oversight Committee (QOC) and oversee associated subcommittees, including China and Japan quality forums, to oversee quality performance across clinical development.
• Represent the GCP Pillar on Quality Governance committee's e.g. Research & Development, Medical (R&DM) Quality and Compliance Committee.
• Member of the Pfizer Quality-Compliance leadership group, maintaining strong interfaces with Regulatory Quality Assurance (RQA), Corporate Audit, Clinical Development Law, and Corporate Compliance.
• Ensure inspection readiness is maintained for all clinical development activities for internal Pfizer and external vendor/partner activities
• Ensure effective review and remediation of RQA audit findings and subsequent CAPA development and effectiveness assessments.
• Improve holistic GCP process quality through oversight and maintenance of the GCP Business Process Owner (BPO) network and the GCP processes.
• Evolve and embed quality risk management strategies.
• Manage and mitigate significant GCP risks.
• Provide direction and oversight to assure effectiveness of key quality systems for clinical development activities, including significant quality event investigation, root cause analysis, management of quality deviation and CAPA and notification to management.
• Ensure review and impact assessment of global GCP regulation changes, ensuring SOP's reflect regulatory requirements and are maintained in a state of control.
• Provide leadership for quality and compliance monitoring, including identifying, analyzing and interpreting key quality indicators, in addition to benchmarking to ensure appropriate application of GCP's within the organization
• Actively participate in the investment and strategy decisions related to the technology decisions for quality.
• Partner with Category Leads to coordinate and assess incoming business development activities and identify SMEs within GRA to support
• Contribute to Regulatory assessments and Due Diligence reports
• Engage with the WRDM and GPD business development teams, due diligence activities including risk assessment of a potential deal in partnership with TA lead
• Establish GRA strategies including resourcing and integration standards in partnership with GRA lines (GRO, CMC, etc.).
• Develop colleagues, including recruitment, retention, and career development for colleagues in the Quality COE.

QUALIFICATIONS / SKILLS

• Education (one of the following): BS and over 15 years or equivalent; or MS and over 12 years or equivalent; or Ph.D./MD and over 10 years or equivalent.
• At least 15 years of experience in managing multiple, highly complex projects with at least 10 years of increasingly responsible positions of staff management.
• Strong clinical development and business experience, including clinical, regulatory, and business development activities
• Proven understanding of effective design and application of a quality management system (including audit, issue, risk, and process management) to ensure GCP compliance.
• Deep knowledge of GCP requirements and applicable SOPs and regulations.
• Project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills.
• Established track record of effectively communicating with ELT-level stakeholders.
• International experience required.

\n

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

\n

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development