Quality Oversight Lead

ROLE SUMMARY:

The Quality Oversight Lead provides analytical expertise and strategic leadership to enable the effective oversight of pharmacovigilance quality and compliance, and to drive continuous quality improvement. This involves contributing to and participating in various quality oversight activities/committees established to drive discussion and action related to mitigating risks to the pharmacovigilance system.

The incumbent leads PVQO efforts to implement and execute a quality framework across pharmacovigilance and regulatory processes and deliverables, including strategies and operational plans for quality data collection, quality metrics/measurements, trending and analysis/reporting of quality metrics, identification of corrective and preventative action planning, and incorporation of continuous improvement methodologies and tools in the continuous quality improvement framework. This involves working with senior leaders, BPOs, business lines, quality groups and governance groups across the organization to drive the implementation of improvement initiatives in response to potential and real risks to pharmacovigilance quality and compliance within the company.

Primary Responsibilities:

Conduct needs assessment with senior leaders and key partners (Pfizer Country Organizations, Clinical, Medical, Development and other supplying organizations), and through external environment analysis to assess PVQO needs in new arenas and identify how our quality systems can evolve to meet these needs and enhance Pfizer’s reputation for supporting high quality and compliance.

• Ensure PVQO is responsive to customer groups, work with site heads and/or heads of functional lines and/or suppliers/PCOs to support resource deployment for service needs and deliverables for product portfolio and relevant processes.
• In collaboration with Head of PVQO develop/evolve relevant processes for quality, compliance, continuous improvement and inspection readiness activities and ad hoc deliverables for products/customers globally.
• Collaborate with Head of PVQO to influence key external regulators with respect to Pfizer’s position relative to Pfizer’s continuous quality improvement activities in the safety and risk management arena and interfaces with regulators, industry groups and other key external stakeholders, as appropriate.
• Serve as a lead quality and compliance expert for the team for functional lines and PCOs, as well as provides advice and guidance to other colleagues and customers/stakeholders, as appropriate.
• Develop effective collaboration with other Clinical, Medical-QA, Manufacturing and Legal Quality functions, linking with key stakeholders across Business Units or Partner Lines, such as Global Product Development and Regulatory, as well as external industry and professional organizations.
• Provide a leadership role and acts as the Subject Matter Expert (SME) on quality and compliance metrics, regulations, process improvements, technology or specific work processes within the pharmacovigilance system.
• Represent PVQO across customer groups and geographic locations and sets the standard for collaborative leadership, continuous quality improvement, delivery of project commitments and customer satisfaction.
• Provide strategic leadership to the delivery of PVQO services, policies and works across stakeholder groups in collaboration with Head of PVQO.
• Provide strategic oversight for the development of quality policies and strategies for customer outputs across sites and customer groups.
• Ensure PVQO services are available across sites and customer groups to ensure needs and deliverables for the processes and products are met and promotes continuous improvement.
• In conjunction with Head of PVQO promote cross-group consistency, standards and strategies across WWS and other partners.
• In conjunction with Head of PVQO foster harmonization across sites, customers and processes for the integrated delivery of PVQO services; champion, maintain and instill a global perspective with a focus on strategy, promoting quality oversight and ‘Right First Time’ initiatives.
• With the Head of PVQO ensure a global understanding of the PVQO vision and its connection to the RDM Quality Management System in support of Business Units and other Partner Lines; foster effective relationships with key internal/external customers and stakeholders.
• Lead virtual teams for process and project-related activities.
• Mentor and coach key PVQO staff as identified by succession plans.

Technical Skill Requirements:

• Clinical, Regulatory and Safety Expertise - Demonstrated knowledge of clinical research processes, safety or regulatory requirements
• Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line. Proficient with software commonly used to present and analyze data (Word, PowerPoint, and Excel) required.
• Scientific/Administrative Excellence - Demonstrated ability to scientifically evaluate and document review and analysis of data. Strong orientation to detail and ability to function independently as appropriate
• Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies
• Project and Process Management & Meeting Established Deadlines – Demonstrated ability to manage complex projects and cross-functional processes, to prioritize accordingly and to meet established deadlines
• Presentation/Influencing/Organizational Skills - Strong platform skills evident. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
• Multitasking – Demonstrated ability to effectively work on simultaneous complex projects/deliverables, prioritizing well, recognizes key issues and recommends course of action to management
• Team and Matrix Structure – Demonstrated ability of effectively working in a team or leading a team in a matrix structure. Can interact at all levels of an organization.
• Analytical and Statistical Skills – Demonstrated ability to analyze, evaluate, understand processes quickly, and identify gaps, issues and opportunities for improvement. Previous experience in KPIs dashboard and data visualization highly desirable.
• Systems Technologies – Thorough understanding of system technologies that support the business.

Qualifications:

Education:

• In general, candidates for this job would have a degree in a science or business related discipline and extensive experience within the pharmaceutical industry:
• BS Degree (or equivalent).
• An advanced degree is desired.

Experience:

• Min 7-10 years clinical development, pharmacovigilance and/or post-marketing and business experience to have a thorough understanding of the processes associated with clinical, safety, pharmacovigilance or regulatory operations.
• Leadership, project management, resource management, administrative, and technical capabilities are required.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Knowledge of organizational development and principles, and associated successful implementation desired.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: On premise

The annual base salary for this position ranges from $134,300.00 to $223,800.00. 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 | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies to the Tampa, FL location only. The salary range provided does not apply to any other United States location or locations 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