ROLE SUMMARY:
The Head, Oncology Quality will report to the Head of Clinical Development and Operations. This position's primary responsibility is to provide leadership and oversight of a team of Global R&D Quality Assurance Professionals in support of multiple early and late phase development programs and is the strategic and operational leader for this group.
This position manages and directs the ongoing Compliance and Quality Assurance activities to support GLP, GCP, GCLP, and other GxP work in ongoing and planned clinical trials, as well as clinical and non-clinical development laboratory activities.
This role requires the proven ability to coach and mentor staff to ensure a high level of quality in our clinical and non-clinical trials and to interact with regulatory authorities to enable successful regulatory inspection outcomes, strong collaboration with internal and external development partners, and effective communication with company leadership.
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This position serves as a subject matter expert to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management.
The Head, Oncology Quality provides inspirational leadership to a team of experienced clinical development and regulatory professionals and balances their role as a champion for their team with company-wide needs.
ROLE RESPONSIBILITIES:
- Global design and strategy, development, deployment, and continuous improvement of RDQ systems and functions, with supporting the entire Pfizer oncology portfolio across all Pfizer Oncology R&D teams
- Directly interact with applicable Development, GPS, Px and Corporate Legal departments and function to assess risk and assure that effective RDQ auditing functions are in place and executed to address company requirements for vendor/subcontractor qualification audits (clinical and nonclinical), global clinical investigator site audits, clinical immunology laboratory audits (internal and external), nonclinical data, internal and external databases (e.g. clinical studies and safety databases), and key deliverables/study components (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).
- Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Senior Leadership, including creation, tracking, and assisting in presenting metrics on the health of Development wide programs and systems on a frequent basis to senior internal and external stakeholders, external collaborators and Senior Leadership.
- Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, CAPA, and deviations.
- Administration and oversight for internal and clinical site training, clinical and nonclinical investigations, databases for the quality system, annual reports and quality trending reports, and evaluation of quality events, incidents, and complaints.
- Provides mentorship, leadership, and prioritization to staff inside and outside of functional area to execute their respective duties.
- Stays current with related quality legislation, compliance issues, and is an internal Pfizer subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents and best industry practices.
- Effectively cooperates and communicates with departments across the company to analyze and resolve quality and technical issues as well mitigate identified risks in accordance with appropriate company standards.
- Supports regulatory inspections as necessary including training applicable Development staff and leading the preparation, conduct, and responses to regulatory agencies.
- Work effectively with the PRD CD&O Quality CoE to ensure cross-Pfizer alignment on quality topics.
- Budget responsibility for Oncology Quality Unit budget
QUALIFICATIONS:
- BS/MS in a related science field; advanced degree desirable
- 20+ years' experience in Clinical Quality Assurance or related field, consisting of 5+ years supervisory experience
- Comprehensive knowledge of drug development process, drug laws, regulations and guidelines
- Ability to work independently and within a group setting and to interact effectively with different functional departments
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
- Ability to establish and build collaborative relationships with senior and executive management, staff, colleagues, and regulatory authorities
- Demonstrates flexibility in dealing with change and diversityPossesses strong critical and logical thinking
The annual base salary for this position ranges from $239,300.00 to $398,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% 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 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