Quality Compliance Lead

Pfizer•Groton, CT

6d•Hybrid

About The Position

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. Position Overview The Quality Compliance Lead serves as a strategic leader and the primary compliance lead within the Groton Pharmaceutical Sciences Quality Assurance (PSOQ) team. This role is pivotal in driving PharmSci (PS) compliance initiatives, developing risk management strategies, and providing quality inspection readiness oversight for GMP/GDP operations across Groton PS, RCMF (Ringaskiddy Clinical Manufacturing Facility), QP operations/activities in Grange Castle and Sandwich, and supporting Medical Device partners. The Quality Compliance Lead ensures applicable facilities adherence to both global regulatory requirements and internal Pfizer quality procedures. Responsibilities include leading complex compliance programs, managing inspection and audits, and overseeing cross-functional projects that reinforce regulatory preparedness and mitigate risks. Supports the PS global internal audit program and RQA internal audit team, driving compliance initiatives and audit programs across multiple Pfizer PS sites.

Requirements

BA/BS with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience in GMP compliance and/or operations quality oversight.
Demonstrated expertise in regulatory requirements, risk management, and audit leadership.
Ability to influence across functions and lead complex projects without direct authority.
Excellent communication and negotiation skills, with experience interfacing with regulatory agencies.
Extensive experience in enterprise-wide compliance leadership and audit management.
Exceptional presentation & facilitation skills with an ability to succinctly & creatively present messages.
Willingness to contribute fresh & innovative ideas
Fluent in English

Nice To Haves

Experience in coaching, developing and influencing people at various levels of the organization.
Independent, quick learner with a curious & lifelong learner mindset.
Candidate demonstrates a breath 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 impact.
Strong project management skills with the ability to manage multiple priorities.
Ability to adapt to changing regulatory environment and business needs.
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.

Responsibilities

Compliance Leadership & Governance Serve as the primary compliance lead for PharmSci Small Molecules (PSSM) PSOQ, offering strategic guidance on global regulations, industry standards, and internal quality policies.
Lead the development and implementation of proactive compliance strategies to cultivate a culture of quality and continuous improvement.
Act as PSOQ compliance lead for regulatory inspections and audits supporting GMP/GDP and ISO requirements.
Collaborate with Pfizer corporate auditors on conducting internal audits.
Lead cross-functional compliance projects across multiple sites with the global PS team to ensure regulatory readiness and reduce risks.
Collaborate with auditors and stakeholders to influence broader processes and standards.
Support Quality Governance activities.
Risk Assessment & Quality Systems Deliver compliance support though risk assessments.
Advise stakeholders on risk prioritization and remediation strategies to ensure consistency with required quality expectations.
May develop and implement risk management strategies for complex, multi-site operations and major capital projects.
Quality Oversight Work with cross-functional teams to implement quality activities and ensure compliance.
Review SOPs and documents for regulatory or internal requirements.
Create and maintain quality tools and conduct compliance training.
Manage quality assessments, risk management, CAPA plans, and/or other compliance documentation.
Track quality metrics to support audit and inspection readiness to ensure compliance.
May oversee compliance aspects for major capital projects, ensuring regulatory and internal standards are met throughout all phases of project lifecycles.
Leadership Impact Lead compliance projects, acting as a strategic leader, that impact multiple sites and contribute to the global PSOQ compliance strategy.
Partner with key stakeholders for quality reviews, audits, investigations, and process improvement initiatives.
Drive innovative solutions to enhance efficiency and compliance across GMP operations.
Acts as a strategic leader, influencing across functions and leading complex projects without direct authority.

Benefits

this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

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