Senior Quality System Specialist

About the role

To provide senior-level quality and compliance expertise in the implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS), ensuring compliance with applicable Good Manufacturing Practice (GMP) requirements, regulatory expectations and company quality standards. The Senior Quality Specialist serves as a subject matter expert in assigned quality systems, drives effective risk-based quality decisions, and partners with cross-functional stakeholders to maintain product quality, patient safety, data integrity, and inspection readiness across the pharmaceutical product lifecycle.

Key responsibilities

• Manage and maintain assigned quality system activities, ensuring compliance with the latest GMP regulations, regulatory requirements and internal procedures.

• Lead and facilitate quality system activities, including deviation management, CAPA, change control, document control, and quality risk management, Complaint Management, Product Recall as assigned.

• Monitor quality system performance through appropriate metrics, trend analysis, periodic reviews, and management reporting.

• Identify systemic issues and drive sustainable improvements in QMS effectiveness.

• Support internal audits, external audits, regulatory inspections and customer assessments.

• Facilitate risk assessments using appropriate methodologies, such as failure mode and effect analysis (FMEA), where applicable.

• Ensure quality risks are appropriately documented, evaluated, mitigated and escalated.

• Lead or facilitate complex deviation investigations and cross-functional problem solving activities.

• Influence stakeholders to make sound quality decisions while maintaining appropriate independence and objectivity.

• Identify opportunities to streamline quality processes while maintaining compliance and effective controls.

About you

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.

• At least 10 years of working experience in production and/or quality management, with a minimum of 7 years in production QA, quality system QA or compliance QA.

• Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.

• Experience in setting up quality systems for new sites is preferred.

• Experience with biopharma commercial quality systems is preferred.

• Proficient in English listening, speaking, reading, and writing.

• Skilled in Microsoft Word, Excel, PowerPoint, etc.

• Strong learning ability.

• Effective at cross-functional communication and collaboration.