The Supplier Quality Assurance (SQA) Officer supports the execution of supplier approval, material qualification, and Contract Manufacturing Organization (CMO) oversight activities for the Health & Wellness division across EMEA.
Reporting to the SQA Manager, this role is responsible for the operational management of supplier and material qualification processes, supplier and CMO audits, and the investigation and resolution of supplier- and CMO-related quality issues and complaints. You will play a key role in ensuring compliance with regulatory requirements, internal quality standards, and risk management principles.
Main Responsibilities
Supplier Approval
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Support qualification and onboarding of new suppliers through documentation review, risk assessments, and quality system evaluation
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Participate in or lead supplier audits (on-site or remote)
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Maintain the Approved Supplier List (ASL) and track approval status
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Support Quality Agreement establishment and lifecycle management
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Coordinate supplier re-evaluation and requalification activities
CMO Qualification & Oversight
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Support onboarding and audit preparation for CMOs
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Participate in CMO audits as assigned
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Assist in reviewing deviations, investigations, CAPAs, and change controls
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Track CMO performance metrics and maintain oversight documentation
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Support Quality Agreement management
Material Approval
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Support qualification of raw materials and packaging components
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Maintain material specifications, CoA requirements, and technical documentation
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Participate in risk assessments and change control reviews
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Monitor material performance trends and escalate concerns
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Maintain the Approved Material List (AML)
Supplier & CMO Complaint Management
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Manage day-to-day handling of complaints and non-conformances
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Coordinate communication with suppliers and CMOs
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Support root cause investigations and CAPA tracking
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Trend complaint data and support reporting
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Escalate critical or recurring issues
Auditing & Compliance
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Conduct or support risk-based audits
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Prepare audit reports and track corrective actions
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Ensure timely closure of audit findings
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Support inspection readiness activities
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Maintain compliance with EU GMP, ISO, and internal standards
Performance & Risk Management
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Maintain supplier and CMO performance scorecards
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Track KPIs related to quality, CAPAs, and audits
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Identify trends and recommend improvements
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Support cross-functional continuous improvement initiatives
Skills & Abilities
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Strong analytical and problem-solving skills
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Detail-oriented with excellent documentation discipline
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Effective communication and stakeholder management
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Ability to manage multiple priorities in a regulated environment
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Structured, risk-based decision-making
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Team-oriented with a continuous improvement mindset
Education & Experience
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Bachelor’s degree in Science, Engineering, Pharmacy, or related field
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3–6+ years’ experience in Quality Assurance or Supplier Quality within GMP-regulated industries
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Experience in supplier qualification, auditing, complaint handling, CAPA management, and quality systems
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Knowledge of EU GMP and EMEA regulatory frameworks preferred
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Auditor certification or training is an advantage
