Quality Oversight and Compliance Director

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. At Pfizer, we are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity.

Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines. Your role will involve interpreting federal, state, and international regulations as they apply to our products, processes, practices, and procedures. You will investigate and resolve compliance issues both within and outside of Pfizer, ensuring that our commitment to excellence and integrity remains steadfast.

The Quality Oversight and Compliance Director is responsible for developing and maintaining Quality Plans, ensuring inspection and audit readiness, providing quality oversight of process deviations, investigations and associated corrective and preventive actions, and driving compliance of pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Clinical) information and processes globally.

The Quality Oversight and Compliance Director works to instil a quality mindset by ensuring the quality and compliance of regulatory processes and product/license information through clearly defined and documented metrics, identifying data trends and addressing associated process risks in collaboration with Regulatory Process Business Process Owners (BPOs) and stakeholders.

The Quality Oversight and Compliance Director works with Regulatory Process BPOs and stakeholders to identify and investigate procedural/compliance gaps and deviations, identify root cause and establish/monitor appropriate remediation plans through timely completion. The Quality Oversight and Compliance Director supports and drives implementation of inspection readiness, audit preparedness and training compliance.

What You Will Achieve

• Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results and drive innovation.
• Identify critical quality process parameters/KPIs to ensure data and process quality and collaborate to create associated Quality Plans and metric reports/dashboards.
• Provide oversight of existing and input to planned processes/systems/controls to ensure that quality is built-in to enable consistent compliance.
• Identify procedural/compliance gaps associated with in scope processes and establishes mitigation and remediation plans with BPOs that provide optimal balance of compliance and business need.
• Drive the investigation, remediation and closeout of Quality Events and associated corrective and preventive actions.
• Drive and support inspection readiness activities and provide remediation support for audit (or inspection) findings.
• Identify opportunities for improvement of pan-regulatory data and business processes and procedures through the definition, management and analysis of metric data in collaboration with BPOs and other stakeholders.
• Leverage relationships to meet the needs of various business units, serving as an advisor and influencing management decisions.
• Make decisions in complex problems, recommend innovative solutions, and support in solving issues impacting business units.
• Act independently on self-initiated projects, using knowledge and judgment in complex decisions within business units.
• Guide Pfizer by interpreting regulations and designing compliance programs, conducting audits, and evaluating policies.
• Provide expertise on quality standards, support partner functions globally, and drive risk management and quality oversight.

Minimum Requirements

• A BA/BS with at least strong experience or an MBA/MS with strong experience or a PhD/JD with experience or an MD/DVM with some experience.
• Profound knowledge of drug development, license maintenance processes, regulatory codes, guidance, and technologies.
• Experience with standard tools of continuous improvement and quality investigations, including DMAIC, root cause analysis, interview techniques and human performance analysis.
• Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and provide consultation as a scientific/technical resource for assigned projects.
• Familiarity with systems and electronic technologies that support regulatory activities.
• Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs and established deadlines.
• Ability to work effectively within or lead a team in a matrix structure.
• Ability to influence without authority.
• Proficiency in Microsoft Office.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.

Preferred Requirements

• A Master's degree (MA/MBA/MS) with over 12 years of experience or a Doctorate (PhD/PharmD/JD) with more than 9 years of experience.
• Proficiency in Lean and/or Six Sigma methodologies.
• Experience in engaging with the external regulatory and pharmaceutical environment.
• A solid understanding of the business and financial landscape.
• Strategic thinking and the ability to develop innovative solutions.
• Experience in risk management and quality oversight.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Work Location Assignment: Hybrid