Quality Compliance Lead

Use Your Power for Purpose

At Pfizer, every action is grounded in a steadfast commitment to delivering safe and effective products to patients. The organization fosters a science- and risk-based quality culture that is flexible, innovative, and customer oriented. Whether your role involves development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient outcomes.

Position Overview

The Quality Compliance Lead serves as a strategic leader and the primary compliance lead within the Andover Pharmaceutical Sciences Quality Assurance (PSOQ) team. This role is pivotal in driving site-wide Pharmsci (PS) compliance initiatives, developing risk management strategies, and providing quality inspection readiness oversight for GMP operations. 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 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.
 

Key Responsibilities

Compliance Leadership & Governance

• Serve as the primary compliance lead for BTx 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.

• 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.

Risk Assessment & Quality Systems

• Deliver compliance support  thorough risk assessments.

• Advise stakeholders on risk prioritization and remediation strategies to ensure consistency with required quality expectations.

• 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.

• 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.

Minimum 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

Bonus points if you have (Preferred requirements)

• Experience in coaching, developing and influencing people at various levels of the organization.

• Independent, quick learner with a curious & lifelong learner m