Supply Operations Quality Lead

Job Description:

Responsibilities

• Quality Leadership & Governance
•  Provide strategic leadership and oversight for all SOQ activities, ensuring alignment and timely implementations of global QMS and SOQ strategy. 
•  Sustain quality governance, escalation to management, and risk management
•  Drive and implement continuous improvement
• Regulatory & Compliance Excellence
•  Ensure continuous compliance with GDP/GxP, local regulatory requirements, and Pfizer Quality Standards. 
•  Maintains inspection readiness and oversight for health authority inspections, internal audits, and suppliers assessments and effective CAPA management
• Suppliers, Partner & Distributor Oversight
•  Ensure effective quality oversight of suppliers, distributors, third party logistics providers, and commercial partners through robust governance
• Product Quality Management
•  Overseeing GMP/GDP and Quality Operations under the scope of SOQ and accountable for the Release for Distribution in India and export markets
•  Act as the primary escalation point for significant product quality events, including complaints, defects, recalls, and quality driven market actions. 
•  Ensure effective investigations, root cause analysis, and sustainable CAPAs for product quality issues. 
• Supply & Business Enablement
•  Act as a trusted quality partner to commercial and Global Supply Chain teams to enable new product launches, market transfer, and business continuity. 
•  Balance compliance with pragmatic, patient centric solutions that support reliable product supply. 
• People Leadership & Capability Building
•  Lead, train and develop Market SOQ resources, fostering accountability, engagement, and succession. 
•  Build a strong quality culture focused on ownership, transparency, and continuous improvement. 
• Stakeholder Management
•  Represent SOQ with external partners and internal senior stakeholders

Qualifications & Experience

• Tertiary qualifications in Pharmacy 
• A minimum of 10 years in the pharmaceutical industry in a Quality role
• A minimum of 5 years leading a team of colleagues
• Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy
• GMP/GDP Knowledge. Trained and experienced in the total application of GMP/GDP and applicable market regulations
• Demonstrated ability to negotiate and influence, particularly with internal senior stakeholders and external parties
• Demonstrated insight and understanding of stakeholders need and business requirements. 
• Strong leadership skills in managing a team and ability to engage and develop direct reports. 
• Excellent Quality Decision making skills. 
• A track record of continuous improvement and balancing efficiencies and effectiveness in processes