Quality and Compliance Lead

3 weeks ago

Groton, United States Pfizer Full time

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

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.

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 clear vision for compliance that aligns with overall business objectives.- Member of the Global Materials Management leadership team, actively contributing to the strategic direction and ensuring adherence to regulatory requirements across all facets of the group.- Demonstrate leadership qualities, serving as a mentor for junior colleagues and fostering a collaborative and growth-oriented environment within the team.- Prepare and present data on quality metrics, compliance status, and improvement initiatives.- Participate on GMM and DPS wide initiatives and limited duration teams.

Innovation- Collaborate with cross-functional teams to develop and implement innovative solutions to improve business processes, reduce compliance risk, whilst driving efficiency.- Stay current on emerging technologies and trends to identify transformational opportunities.- Collaborate closely with the GMM strategy and project team to ensure harmonious integration of compliance and innovation, fostering cohesive partnerships to advance initiatives.

Risk Management- Manage GMMs quality and compliance systems, leveraging data to analyze trends and KPIs.- Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, change control and validation activities.

Training and SOP Management:
- Develop and implement training programs to enhance employee skills and process knowledge. Measure training effectiveness and make necessary improvements. Assure GMM remains informed about the latest GMP requirements and trends.- Author, review, maintain and update Standard Operating Procedures (SOPs).

Operational Excellence and Continuous Improvement:
- Establish feedback mecha

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