Senior QA Compliance & Auditing Manager (GMP/GDP)

Idorsia seeks a Senior QA Compliance & Auditing Manager in Allschwil to lead GMP/GDP compliance, supplier oversight, and audit programs within its Global Quality Management team.

This position sits within the Compliance & Auditing Team under Global Quality Management. The primary purpose of the role is to safeguard operational integrity by ensuring strict adherence to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards across all relevant activities.

Responsibilities

• Direct the full lifecycle of supplier qualification and oversight, applying risk-based methodologies to maintain rigorous standards.
• Oversee the creation, negotiation, and upkeep of Technical Quality Agreements (TQAs) with external partners.
• Plan, conduct, and report on GMP/GDP audits for suppliers, contractors, distributors, and service providers, including follow-up actions.
• Manage the annual external audit schedule and internal self-inspection calendar.
• Review and approve change controls, deviations, corrective and preventive actions (CAPAs), and investigations.
• Develop, review, and maintain quality procedures and compliance documentation to ensure inspection readiness.
• Coordinate with internal teams to support Health Authority inspections and customer audits.
• Track regulatory changes in GMP/GDP and implement necessary compliance updates proactively.
• Optimize the quality system by monitoring KPIs, quality metrics, and leading continuous improvement initiatives.
• Escalate critical compliance risks and audit findings to management, ensuring effective resolution.
• Support cross-functional compliance efforts in areas such as CSV, Data Integrity, Pharmacovigilance (GVP), and Clinical Quality (GCP).
• Foster a strong quality culture and GxP mindset throughout the organization.
• Travel domestically and internationally to perform supplier qualifications and audit activities.

Requirements

• University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific field.
• At least seven years of experience in pharmaceutical Quality Assurance, Compliance, Supplier Quality, Manufacturing Quality, or similar GxP roles.
• Proven track record of managing supplier qualification programs and serving as a Lead Auditor for GMP/GDP audits.
• Deep understanding of pharmaceutical development, manufacturing, packaging, testing, storage, and distribution processes.
• Expert knowledge of EU GMP, EU GDP, ICH, PIC/S, WHO, FDA, and ISO regulations.
• Ability to interpret regulations independently and implement pragmatic, risk-based compliance solutions.
• Experience in developing and managing Quality Agreements and external partner oversight programs.
• Strong project management capabilities.
• Excellent analytical, organizational, and problem-solving skills.
• Confident, proactive demeanor with the ability to influence stakeholders at all levels.
• Strong interpersonal, communication, and leadership abilities.
• Fluent proficiency in English.

Nice to have

• Master's degree in a relevant field.
• Knowledge of additional GxP areas such as Pharmacovigilance (GVP), Clinical Quality (GCP), Computerized Systems Validation (CSV), or Data Integrity.
• Proficiency in another European language.

What the company offers

• Permanent, full-time employment contract.

About the company

Idorsia leverages diversity, authenticity, and inclusion as core drivers for business success, fostering an environment where different perspectives contribute to achieving organizational goals.

• The company values difference, authenticity, and inclusion to drive business outcomes.