Head, Clinical Development & Operations Quality
Biopharma Careers
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Job summary
Pfizer seeks a senior leader to define and lead the global GCP quality strategy across Clinical Development & Operations, reporting to the Head of CD&O. You will provide independent advice on quality and regulatory risks, ensuring data integrity and patient protection across a global portfolio.
The role leads a distributed team and partners with Regulatory Quality Assurance, Legal, Digital and external partners to advance quality, risk governance and proactive remediation.
Qualifications
- 12+ years of advanced scientific, medical, pharmacy, regulatory, quality or related experience.
- Extensive leadership across GCP quality, clinical development and regulatory compliance.
- Global clinical-trial conduct expertise and interpretation of GCP requirements.
- Accountability for enterprise quality strategy and portfolio risk management.
- Ability to advise executive leaders on decisions involving regulatory, data and participant risk.
- Experience leading organizational or operating-model transformation while sustaining quality.
- Governance across complex global matrix organizations and external partnerships.
- Ability to lead through ambiguity and drive clear executive decisions.
Responsibilities
- Set enterprise GCP quality strategy aligned with portfolio strategy and regulatory obligations.
- Chair the GCP Quality Oversight Committee and elevate material risks to executive governance bodies.
- Provide strategic quality oversight across global Phase I-IV portfolio focusing on high-risk assets and processes.
- Lead AI, digital and data-enabled quality framework across clinical development.
- Embed quality by design and proactive risk management into portfolio planning, protocols and vendor models.
Skills
Education
Job description
The Head, Clinical Development & Operations (CD&O) Quality is the senior leader accountable for defining and leading the global GCP quality, compliance and integrity strategy across Clinical Development & Operations. Reporting to the Head of Clinical Development & Operations and serving as a member of the CD&O Leadership Team, this leader provides independent, authoritative advice on the quality and regulatory risks associated with Pfizer's global clinical-development portfolio, operating model, technology strategy, external partnerships and organizational transformation.
The role holds enterprise accountability for the effectiveness and continued evolution of the GCP quality-management framework across clinical development, from first-in-human studies through post-approval commitments. The leader establishes the governance, standards, decision frameworks and management insights required to protect clinical-trial participants, preserve data integrity, maintain regulatory compliance and support reliable portfolio delivery across therapeutic areas, regions and operating models.
The Head of CD&O Quality advises CD&O and R&D leadership on material quality risks and their implications for portfolio priorities, investment decisions, clinical-trial design and conduct, vendor and partner strategies, acquisitions and integrations, and the deployment of AI and digital capabilities. The role has authority to accelerate significant risks, require appropriate mitigation and challenge or recommend changes to business decisions when quality, compliance, participant protection or data integrity may be compromised.
This leader represents CD&O in senior quality, compliance and risk-governance forums and maintains critical relationships with Regulatory Quality Assurance, Legal, Corporate Compliance, Digital, clinical-development leaders, health authorities and external partners. The role builds a culture in which quality is embedded in business decisions and owned at every level, positioning quality as an enabler of innovation, speed and sustainable clinical-development performance rather than as a downstream control.
The role leads a globally distributed organization of senior quality professionals and leaders, setting the long-term capability, talent, technology, resource and operating-model strategy required for a future-ready, data-driven and AI-enabled quality organization.
Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O, aligned with Pfizer portfolio strategy, regulatory obligations, the Purpose Blueprint and the evolving clinical-development model.
Own the enterprise framework through which CD&O assesses, understands and communicates its state of GCP quality, integrating leading and lagging indicators, emerging regulatory expectations, operational data, audit and inspection outcomes, and quality-event trends.
Translate quality intelligence into strategic recommendations for CD&O and R&D leadership, including implications for portfolio priorities, operating-model design, capability investment, resourcing and risk acceptance.
Design and lead an integrated, risk-based GCP quality-governance model with clear decision rights, escalation thresholds, accountability and interfaces across CD&O, R&D, Regulatory Quality Assurance, Legal, Corporate Compliance, Digital and other quality pillars.
Chair the GCP Quality Oversight Committee and ensure material quality risks, systemic trends and remediation priorities are elevated to the appropriate executive governance bodies with clear recommendations and accountable decisions.
Exercise independent judgment and constructive challenge when clinical-development, portfolio, financial, technology or operating-model decisions may create unacceptable risk to participants, data integrity, regulatory compliance or Pfizer's ability to defend its clinical evidence.
Provide strategic quality oversight across the global Phase I-IV portfolio, focusing leadership attention and resources on the assets, studies, partners and processes presenting the greatest participant, data-integrity, regulatory or business risk.
Ensure inspection readiness for pivotal trials, submissions and major regulatory interactions, and act as the senior CD&O quality representative in significant sponsor inspections, regulatory engagements and executive remediation decisions.
Ensure significant quality issues are identified early, investigated rigorously, remediated sustainably and used to drive portfolio-wide learning and prevention.
Define the GCP quality and compliance framework for the responsible design, validation, deployment, oversight and lifecycle management of AI-enabled and digital capabilities used in clinical development.
Partner with Digital, Data, Legal, Compliance and business leaders to ensure AI innovation incorporates appropriate human accountability, explainability, data integrity, risk controls and regulatory readiness from design through sustained use.
Sponsor modernization of quality intelligence through integrated data, predictive indicators, automation and AI-enabled insights, with measurable improvement in risk detection, decision quality, inspection readiness and operational performance.
Determine when existing processes, controls and governance must be redesigned rather than merely automated, ensuring technology reduces complexity instead of embedding it.
Embed quality by design and proactive risk management into portfolio planning, protocol and operational strategy, study execution, vendor models and technology transformation.
Establish pragmatic, risk-proportionate frameworks that enable innovation and speed while maintaining participant protection, data integrity and regulatory compliance.
Build quality ownership across CD&O so operational teams retain accountability for the quality of their work, supported by expert guidance, independent oversight and clear escalation pathways.
Set the enterprise quality strategy and risk framework for CROs, vendors, site organizations, strategic partners, licensed partners and other third parties supporting clinical development.
Ensure risk-based due diligence, contracting expectations, oversight, performance intelligence and escalation are proportionate to the criticality and complexity of externally performed work.
Establish the GCP quality approach for acquisitions, integrations and new operating models, ensuring quality risks are understood before decisions are finalized and post-close obligations are governed through completion.
Represent Pfizer externally with regulators, industry bodies and strategic partners to anticipate regulatory change and help shape the evolution of quality practice in clinical research.
Provide executive leadership for systemic quality remediation, ensuring root causes are addressed across process, technology, capability, governance and culture rather than through isolated corrective actions.
Establish mechanisms to translate quality events, audits, inspections and near misses into enterprise learning, preventive action and measurable improvements in clinical-trial execution.
Ensure transparent accountability for remediation commitments, including appropriate challenge of timelines, resources, evidence of effectiveness and residual risk.
Lead and develop a globally distributed organization of senior quality leaders and professionals, establishing clear strategic ownership, decision authority and accountability at every level.
Own the long-term organizational, skills, succession, workforce, technology and sourcing strategy for CD&O Quality, ensuring the organization has the capabilities required for evolving regulations, operating models, data and AI.
Set resource and investment priorities across the quality portfolio, directing expertise and capacity towards the areas of highest enterprise risk and strategic value.
Create a culture of integrity, inclusion, transparency, constructive challenge, continuous learning and accountable delivery.
- 12+ years of advanced scientific, medical, pharmacy, regulatory, quality or related degree, or equivalent depth of relevant professional experience.
- Extensive progressive leadership experience across GCP quality, clinical development, clinical operations, regulatory compliance or related disciplines, including significant experience leading senior leaders in a complex global organization.
- Deep, first-hand expertise in global clinical-trial conduct across Phase I-IV and in the interpretation and application of GCP requirements across major regulatory jurisdictions.
- Demonstrated accountability for enterprise quality strategy, clinical quality systems, portfolio risk management, regulatory inspections and complex remediation.
- Proven ability to advise and influence executive leaders on decisions involving significant regulatory, participant, data-integrity, reputational and business risk.
- Demonstrated success leading organizational or operating-model transformation while sustaining quality, compliance and business continuity.
- Experience establishing governance, decision rights and accountability across complex global matrix organizations and external partner networks.
- Demonstrated ability to lead through ambiguity, challenge constructively, make enterprise trade-offs and convert complex quality information into clear executive decision.
- Experience engaging directly with major global health authorities on inspections, significant quality matters or evolving GCP expectations.
- Experience shaping quality strategy for AI, digital technologies, advanced analytics, decentralized or novel trial approaches.
- Experience with acquisitions, integrations, alliances or other business models that introduce complex GCP quality and third-party risk.
- External industry leadership through professional bodies, regulatory forums, standards development or recognized thought leadership in clinical quality.
- Track record of building global leadership teams, succession pipelines and future-facing quality capabilities.
- Strong business and financial acumen, including resource prioritization and investment decisions in a global portfolio environment.
- Head of Clinical Development & Operations and the CD&O Leadership Team.
- R&D executive leadership and enterprise quality, compliance and risk-governance bodies.
- Clinical Development, Global Site & Study Operations, Clinical Data & Information Sciences, Global Clinical Supply, Medical Writing and other CD&O functions.
- Regulatory Quality Assurance, Global Regulatory Sciences, Safety, Legal, Corporate Compliance and the Chief Quality Officer organization.
- Digital, Data, AI, Cybersecurity, Finance, Business Development and People Experience organizations.
- Global health authorities, CROs, strategic providers, technology partners, site organizations, licensed partners, industry consortia and professional associations.
- Global organization of quality leaders and professionals across multiple geographies, including leadership of leaders, senior individual contributors and externally sourced capabilities.
- Matrix leadership across therapeutic-area, portfolio, regional and functional quality networks.
- Accountability for organizational operating budget and external-service expenditure within assigned authority.
- Prioritization of quality technology, analytics, AI, inspection-readiness and remediation investments.
- Allocation of quality expertise and capacity based on portfolio risk, regulatory priorities and organizational capability needs.
- Enterprise influence over quality strategy and risk oversight across the global CD&O portfolio and external partner network.
The annual base salary for this position ranges from $300,100.00 to $500,100.00. 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.
- 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
- 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.
This role may be posted in multiple locations. If you are applying for the role in a secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
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