Quality and Compliance Lead - Drug Product Supply Global Materials Management

Why Patients Need You

The Drug Product Supply Global Materials Management team plays a pivotal role in assuring our breakthroughs make it to the hands of patients. At Pfizer, our Global Materials Management group (GMM) is responsible for all demand planning, sourcing, and material handling for products supporting the Pfizer clinical supply chain and portfolio. By leading and supporting the quality and compliance aspects of GMM, you will be driving best-in-class compliance practices, making our work compliant, more efficient, and allowing GMM to better supply our patients and continuously achieve breakthroughs that change patients’ lives.

What You Will Achieve

Pfizer’s Pharmaceutical Sciences Drug Product Supply group is seeking a highly skilled, detail-oriented, and forward-thinking Quality and Compliance Lead with a focus on GMP principals across our Global Materials Management group.  The successful candidate will ensure the highest level of quality and compliance across all aspects of GMM, collaborating with GMM leadership. The chosen candidate will be responsible for implementing and maintaining quality management systems and policies in accordance with regulatory requirements, Pfizer standards and industry best practices. The Quality and Compliance Lead will also play a key role in driving technology and innovation initiatives to enhance efficiency and effectiveness across the quality and compliance functions.

In this dynamic position, you will spearhead a comprehensive compliance strategy, ensuring alignment with regulatory and Pfizer standards, fostering a culture of excellence, and harmonizing practices for GMM across diverse and geographically dispersed facilities.

The successful candidate will be responsible for driving compliance related innovation while leading improvement teams/projects, ensuring effective implementations and operational compliance. The candidate will manage global/local trainings and SOPs, including trending and KPI’s of compliance data.

The candidate will work closely with all GMM team members and collaboratively with a vast number of partner lines to support all facets of GMM operations/facilities. Remit will span across both small and large molecule.

How you Will Achieve It

Regulatory Compliance

• Interpret and stay updated on relevant regulation and guidelines from health authorities.

• Represent GMM at the Pharm Sci monthly compliance meeting.

• Become Subject Matter Expert (SME) and stay updated on relevant Pfizer Quality Standards (PQS).

• Lead and support investigations related to materials, facilities, non-conformance, and supplier quality issues.

• Ensure that all processes, documentation, facilities, and products comply with requirements.

• Support regulatory and internal inspections/audits, collaborating with GMM leaders in addressing any findings and implementing corrective and preventive actions (CAPAs).

• Build and execute a self-inspection program to drive and monitor GMP compliance and identify potential areas for improvement.

• Lead GMM compliance forum and appropriate PQS teams.

• Participate in highly matrixed cross-functional teams with operational leaders to prioritize strategic processes and roadmaps and drive innovation.

• Oversight and support of partner groups working within GMM facilities (i.e. GCS, DPM, GWE).

• Support GMM controlled substance program (DEA & CT Drug Control).

GMP (Good Manufacturing Practices) Compliance

• Set the strategic direction for quality and compliance throughout GMM.

• Assure adherence to established GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business.

• Assure comprehensive framework of practices, procedures and documentation requirements are in place and being always adhered to across the GMM.

• Ensure a proactive and adaptive approach to evolving business landscapes. Champion the implementation of efficient and compliant processes.

• Establish and maintain a seamless connection between materials management processes and overall quality initiatives through fostering a culture of quality and continuous improvement.

• Lead and review quality/compliance documentation and implement processes to improve speed while focusing on quality, compliance and Right-First-Time (RFT).

• Use a quality embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions.

Leadership

• Provide strategic direction in interpreting and implementing evolving regulatory standards.

• Develop and articulate a