OneSource Account Quality Specialist

Quality Leadership & Coordination

Act as the primary on-site quality SME and escalation point.
Lead and coordinate quality activities across the account team.
Promote a strong quality culture and influence without direct authority.

Auditing & Inspection Readiness (Proactive Focus)

Plan and conduct internal, supplier, and process audits.
Support customer, self-inspections, and regulatory inspections.
Track audit findings, non-conformances, and CAPA effectiveness.

Deviation, CAPA & Change Control (Reactive Support)

Oversee and support investigations, root cause analysis, and CAPA.
Ensure timely closure of quality events with minimal operational impact.
Review and approve quality records in line with delegated authority.

Training & Quality Awareness

Own the site quality training program with site leadership.
Deliver GMP and QMS training and ensure compliance and effectiveness.
Drive awareness and accountability for quality across all site employees.

Supplier Quality Oversight

Support supplier qualification, audits, and performance monitoring.
Ensure supplier compliance with QMS and Quality Agreement.
Address supplier-related quality issues with stakeholders.

Continuous Improvement

Support delivery of the site quality plan and improvement initiatives.
Analyze quality trends and drive actions to enhance performance.
Report on quality metrics and audit outcomes to stakeholders.

Basic Qualifications

• Bachelor’s degree in a relevant field or equivalent professional experience with a minimum 3 years’ experience in quality assurance within a GxP/pharmaceutical environment.
• Demonstrated experience with QMS processes (deviations, CAPA, change control, audits).
• Strong knowledge of GMP and regulatory expectations.
• Communicate fluently in English. Ability to lead and influence without direct authority.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and stakeholder management skills.

Preferred Characteristics

• Strong working knowledge of Quality Management Systems in GxP environments.
• Proficiency in auditing (internal, supplier, and external inspection readiness).
• Solid understanding of GMP regulations and Good Documentation Practices.
• Ability to balance proactive and reactive quality priorities in a dynamic environment.
• Proficiency in SAP, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint.
• Certified Quality Auditor (CQA) or equivalent certification.
• Experience with Lean / Six Sigma methodologies.
• Experience working in customer-embedded or outsourced service environments.