Pfizer
Contractor Quality Lead
- Permanent
- Riyadh, Saudi Arabia
- Experience 10 - 15 yrs
Job expiry date: 18/05/2026
Job overview
Date posted
03/04/2026
Location
Riyadh, Saudi Arabia
Salary
SAR 30,000 - 40,000 per month
Compensation
Comprehensive package
Job description
The Contractor Quality Lead within Pfizer Global Supply External Supply Operations Quality (ESOQ) is responsible for ensuring the quality, compliance, and regulatory oversight of products manufactured and packaged by external contract manufacturers, packagers, contract testing organizations (CTO), and suppliers globally. The role operates within Pfizer Global Supply (PGS) to support approximately 300 global contract manufacturers and supply partners, ensuring adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), regulatory requirements, and internal Pfizer quality standards. The Contractor Quality Lead manages complex portfolios of external suppliers, performs risk-based quality management, supports onboarding and offboarding of CMOs, oversees product launches, conducts quality assessments, supports audits and regulatory inspections, and ensures compliance with ICH guidelines and global regulatory standards. The role includes reviewing Annual Product Review (APR) and Product Quality Review (PQR), endorsing batch disposition, managing stability studies, leading investigations, managing risk assessments, supporting Quality Improvement Plans, and providing quality leadership within cross-functional virtual site operating teams (VSOT). The position requires strong expertise in enterprise systems including SAP, QTS, Vault, Documentum, and Minitab, along with advanced knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory compliance. The Contractor Quality Lead collaborates with cross-functional teams including Regulatory, Technical Support, Manufacturing, External Supply, Quality, and R&D to ensure product quality, drive continuous improvement, and support innovation initiatives while maintaining high-level stakeholder relationships and delivering operational excellence across global supply networks.
Required skills
Key responsibilities
- Manage all aspects of product quality and compliance for a complex portfolio of external contract manufacturers, contract testing organizations, and suppliers ensuring compliance with GMP, GDP, and global regulatory standards while supporting delivery of high-quality products on time
- Assess supplier product quality, manufacturing processes, documentation, and quality systems while ensuring compliance with specifications, regulatory requirements, and Pfizer quality standards across global supply networks
- Support internal and external audits including RQA audits and regulatory inspections, conduct compliance assessments, and manage corrective and preventive actions for identified quality gaps
- Lead risk management activities at vendor sites including risk assessments, Quality Risk Teams (QRTs), Quality Action Notices (QANs), and implementation of Quality Improvement Plans
- Support onboarding of new contract manufacturing organizations and product launches, as well as offboarding activities for exiting CMOs, products, and SKUs
- Provide quality leadership in cross-functional virtual site operating teams, collaborate with Regulatory, External Supply, Quality, R&D, and Manufacturing teams, and influence quality decision-making across stakeholders
- Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), stability reports, and endorse batch disposition decisions in alignment with regulatory requirements
- Lead complex investigations, market complaints, deviation management, and root cause analysis while ensuring proper escalation and documentation
- Develop and implement continuous improvement initiatives to enhance ESOQ processes and maintain compliance with evolving internal and regulatory standards
- Track quality performance metrics and KPIs, maintain documentation in enterprise systems, and ensure adherence to escalation procedures
- Partner with stakeholders to negotiate and manage quality agreements and supplier quality relationships
- Support stability studies conducted at CMO and CTO sites ensuring compliance with approved protocols and ICH guidance
- Lead cross-functional projects and initiatives across global teams while anticipating risks and ensuring milestone delivery
- Act as backup to Site Quality Operations Lead and support ESOQ leadership initiatives as required
Experience & skills
- Bachelor of Science degree in Pharmacy, Engineering, or related technical discipline
- Minimum 10 years of experience in pharmaceutical or medical device quality assurance roles or 15 years industry experience
- Experience managing external suppliers, contract manufacturers, and global quality operations
- Advanced knowledge of GMP, GDP, global cGMP regulations, and regulatory compliance requirements
- Experience with audits, regulatory inspections, and quality system oversight
- Advanced computer skills including MS Office and enterprise systems such as SAP, QTS, Vault, Documentum, and Minitab
- Proficiency in English and technical writing skills
- Demonstrated leadership in managing cross-functional teams and complex global projects
- Experience managing complex quality investigations, compliance activities, and risk assessments
- Strong stakeholder management, communication, and presentation skills
- Ability to work independently and lead initiatives with minimal supervision
- Demonstrated conflict resolution and organizational skills
- Experience with quality agreements, stability studies, APR/PQR reviews, and batch disposition
- Strong planning and organizational capabilities with ability to manage multiple priorities
- Knowledge of ICH guidelines and global regulatory frameworks
- Ability to work in hybrid environments and across global time zones