Quality Oversight and Compliance Director

Pfizer

. Your role will involve interpreting federal, state, and international regulations as they apply to our products, processes, practices, and procedures.

Posted 5/6/2026full-time🇬🇧 United KingdomLeadWebsite

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug developmentlicense maintenance processesregulatory codesguidanceDMAICroot cause analysisinterview techniqueshuman performance analysisquality investigationsquality standards

Soft Skills

analytical skillsproblem-solving skillscommunication skillsinfluence without authorityteam leadershipstakeholder engagementdecision-makingproject managementconsultationcollaboration

Certifications

BA/BSMBA/MSPhD/JDMD/DVM