Quality Assurance Team Lead

Role Purpose

The Commercial Quality Team Lead is responsible for ensuring that commercial operations comply with applicable quality systems, procedures, and regulatory requirements across regulated product categories (e.g. medicines, medical devices, cosmetics, food supplements). The role balances compliance with business enablement, working closely with internal teams, manufacturing sites, distributors, third parties, and external authorities.

Key Responsibilities

Commercial Quality Leadership

• Act as the commercial quality lead and primary quality contact for assigned international markets
• Provide quality oversight for the commercial product portfolio
• Support resolution of quality, compliance, and product safety issues in market
• Lead team members

Quality Management System (QMS)

• Support local leadership in implementing and maintaining an effective, inspection-ready QMS
• Drive continuous improvement, change management, and quality initiatives
• Ensure compliance with global policies, procedures, and Good Distribution Practices (GDP)
• Lead training on QMS requirements and relevant regulatory changes
• Manage deviations, complaints, critical events, and CAPAs
• Oversee document control, SOP approval, and technical agreements
• Lead product recall readiness, including mock recalls
• Perform risk assessment, trending, and mitigation activities
• Report QMS performance through metrics, KPIs, and management reviews

Third-Party Oversight

• Ensure quality oversight of freight, distribution, co-packing, and outsourced activities
• Conduct qualification, approval, and ongoing compliance monitoring of third parties
• Define quality expectations through technical and quality agreements

Audits \& Inspections

• Coordinate and host regulatory inspections and third-party audits
• Manage follow-up actions and timely closure of CAPAs

Cross-Functional Collaboration

• Partner with manufacturing, quality, regulatory, operations, legal, and commercial teams to ensure consistent product quality and compliance

Qualifications \& Experience

• Master’s degree in Quality, Chemistry, Regulatory Affairs, Pharmacy, or related field
• Minimum 10 years’ experience in a quality role within a regulated industry (pharma, healthcare, medical devices, cosmetics, or similar)
• Strong experience designing, implementing, and maintaining QMS
• Solid understanding of GMP, GDP, and relevant regulatory frameworks
• Auditing experience preferred

Key Competencies

• Strong leadership and influencing skills in matrix environments
• Results-driven with a proactive, hands-on mindset
• Ability to assess and manage quality and compliance risks
• Commercial awareness and pragmatic decision-making
• Excellent communication and presentation skills
• Comfortable operating in complex, international settings
• Fluent in English (additional languages an advantage)