- Location
- IND - Mumbai, India
- Type
- Full-time
- Department
- Operations
- Seniority
- Lead
- Closing date
- Today
- Source
- Workday
Description
The Supply Operations Quality (SOQ) Lead –is accountable for providing end‑to‑end Supply Operations Quality leadership in India, ensuring regulatory compliance, inspection readiness, robust suppliers oversight, and a strong quality culture that enables uninterrupted supply and patient safety. The role acts as a strategic quality business partner to Pfizer India as a core Leadership Team (LT) member, Global supply chain, and external partners, translating global quality requirements into effective local execution.
The SOQ Lead will be accountable for the implementation and compliance to SOQ Functional and Global SOPs and any other Pfizer Quality Standard requirements. It will be the primary contact point for business partners both internal and external. It will be responsible for the management of the SOQ India development and organisation of the team reporting into it. It will also be accountable for the supply of compliant product into India and neighbouring markets and act as a GMP/GDP Compliance role model for areas of responsibility by educating the team and ensuring adherence to Good Manufacturing Practice and Good Distribution Practice for Medicinal Products.
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
Able to demonstrate good planning and organisation skills
High level of self-integrity and ethical conduct
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Quality Assurance and Control
