Head of GCP Audit

The Head of GCP Audit is the single point of contact responsible for developing a holistic quality audit strategy that identifies potential risk areas and assures the state of quality for all clinical development activities , leveraging available quality data to identify risks, corresponding mitigation activities, and providing strategic guidance based on these findings. They partner with other functional management/leaders across WRD, GPD, and Upjohn . The Head of GCP Audit acts as an enterprise leader and mentor for their Quality Assurance Colleagues; developing and growing talent to ensure team capabilities are aligned with RQA business strategy. They work to ensure Pfizer quality standards are aligned with key industry trends.

ROLE RESPONSIBILITIES

Leadership

• Acts as an enterprise leader in Quality, influencing and partnering with other functional management/leaders across WRD, GPD, Upjohn and Medical, to develop, evolve and strengthen a holistic quality strategy that encompasses all GCP activities, including functional business lines, level 3 (Corporate Audit) and Corporate Compliance. Sets behavioral and relationship building standard for others to aspire to in RQA and Quality. Leverages relationships to achieve goals.
• Develops vision for future quality oversight and quality assurance professional skills that are needed. Identifies leadership potential and develops the next generation of leaders within RQA and Quality. Deploy key talent against critical business strategies to ensure capabilities are aligned across RQA. Ensure RQA strategy and capabilities are aligned across the Pfizer portfolio and RQA more broadly
• Innovates by challenging the status quo to create new strategies and solutions that are enterprise focused. Interact with and influence peers across the portfolio of Clinical Development activities and senior functional line leaders
• During integration, accountable for setting vision for integration quality strategy, in partnership with non- RQA Pfizer leaders. May be responsible for leading cross functional quality integration committee. Ensure appropriate risk mitigation across the clinical development portfolio.

Audit Strategy

• Lead and represent RQA’s audit strategy through holistic leadership within Quality and across Pfizer. Ensure alignment of the GCP audit strategy with other GxP pillars within the R&D QMS. Define and drive consistency of audit process and standards across the portfolio and within RQA
• Accountable for the development of a cross portfolio, cross functional risk management strategy. Represents RQA in GCP/Clinical quality governance activities. Accountable for high quality execution of the global audit program for all of R&D Good Clinical Practices (GCP) & Submission activities
• Responsible for effectively forecasting RQA portfolio resources and identifying and allocating QA talent

Risk/Quality Management

• Contributes to the advancement of development of regulatory strategies by proactively identifying risks and challenges across the portfolio using available quality data. Ensure state of control is accurately represented at relevant quality governance committees (e.g., QOC and to the R&D and Medical Quality Compliance Committee)
• Represents Pfizer RQA strategy at industry forums and regulatory agency interactions
• Monitors the state of quality within the GCP QMS pillar, communicates trends to cross-functional leaders, and provides strategic guidance based on findings

Operational Excellence

• Works to ensure quality standards are consistently applied across the business unit and within RQA
• Drive strategies for continual improvement of Clinical Development activities and maintain insight to cross-GxP continuous improvement projects under the umbrella of the QMS. Maintains current knowledge of industry quality trends

People Management

• Grow leaders by providing challenging and stretching tasks and assignments, being aware of each direct reports’ goals, mutually constructs compelling development plans and executes them, encourages people to accept developmental moves
• Is aligned with RQA culture, values and mission, leads others to act in a manner aligned with RQA organizational culture, value and mission, communicates a compelling and inspired vision or sense of core purposes, talks beyond today, creates mileposts and symbols to rally support behind the vision, inspires and motivates the portfolios and audit team

QUALIFICATIONS

• Bachelor’s degree experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered.
• 15+ years Quality Assurance or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy.
• 10+ years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
• Expertise and strong background in GCP, PV, GLP or other related quality areas
• Prior teaching and coaching experience as a People Manager
• Proven ability to think innovatively and to develop and execute strategic plans pursuant to the responsibilities of the role

Non- Standard Work Schedule, Travel or Environmental Requirements

Travel Required approx. 20%

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.

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.

Other Job Details:

• Last Date to Apply for Job: December 20, 2019
• Preferred Location: Any Pfizer Site in North America
• #LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control