Associate Principal QA Specialist

In this role you will provide hands-on QA review and guidance to ensure GMP compliance across studies and activities. You will act as a GMP SME, shaping quality processes and supporting operations to stay compliant. You will drive issues to resolution via the QMS and governance forums, while promoting a culture of quality and continuous improvement. This fully site-based position partners with senior QA leaders to identify improvements and maintain high standards in Development Services and related functions.

• agile career and dynamic culture
• inclusive workplace
• competitive compensation
• role-based benefits
• global benefits overview

• Provide QA review, approval and guidance for deviations, CAPAs, change controls, investigations, and OOS records to ensure timely, compliant resolution
• Identify, manage and escalate major and critical compliance issues through the QMS and governance forums
• Provide QA oversight for QC, MSAT, and Development Services activities including studies, method validation, reference standards, tech transfer and stability programmes
• Act as QA/GMP Subject Matter Expert, offering strategic quality guidance to Operations, QC, MSAT and Development Services
• Mentor and develop team members and partners in cGMP principles to foster a strong quality culture
• Maintain audit readiness via area walkthroughs, process audits, and support for inspections; proactively address compliance gaps
• Lead continuous improvement initiatives and quality system enhancements through cross-functional collaboration

• BSc or equivalent in a scientific subject (preferred)
• Strong business and interpersonal communication skills
• Experience in developing and implementing QA plans for technical operations
• Experience conducting quality audits and inspections of technical processes
• Ability to identify non-conformances and drive corrective actions
• Experience collaborating with technical teams to implement quality improvements
• Proficiency in reporting quality metrics and KPIs to stakeholders

• persuasive communication
• active listening
• collaboration
• GMP knowledge
• Quality Management System (QMS) administration
• Quality audits and inspections