Senior QA Compliance & Auditing Manager (GMP/GDP)

Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for a Senior QA Compliance and Auditing Manager to join our Compliance & Auditing Team!

Job Responsibilities

As a Senior QA Compliance and Auditing Manager, you will play a key role in ensuring GMP/GDP compliance across our operations. Main tasks will include:

• Lead and manage the supplier qualification and lifecycle management program, including qualification, periodic evaluation, requalification, and performance monitoring of GMP/GDP service providers and suppliers.

• Support the design, negotiation, implementation, and maintenance of Technical Quality Agreements (TQAs) and other quality-related contracts with external partners.

• Establish, maintain, and continuously improve supplier oversight processes using a risk-based approach.

• Lead the planning, execution, reporting, and follow-up of GMP/GDP audits of suppliers, contractors, distributors, and service providers.

• Participate in the establishment and oversight of the annual external audit program and internal self-inspection schedule based on risk assessment.

• Promptly escalate critical compliance risks and audit findings to management and ensure effective CAPA implementation.

• Manage, review, and approve change controls, deviations, CAPAs and investigations.

• Lead the development, review, and maintenance of quality procedures and compliance-related documentation.

• Manage and maintain quality documentation systems and ensure inspection readiness.

• Coordinate and support Health Authority inspections and customer audits.

• Monitor evolving GMP/GDP regulations and industry expectations and proactively implement necessary compliance improvements.

• Support the optimization of the Quality System through KPI monitoring, quality metrics, management reviews, and continuous improvement initiatives.
• Support cross-functional compliance activities and quality initiatives as needed, including Computerized Systems Validation (CSV), Data Integrity, Pharmacovigilance (GVP), Clinical Quality (GCP), and other GxP-related compliance tasks.

• Promote a strong quality culture and GxP mindset across the organization.

• Travel domestically and internationally as required to support supplier qualifications and audit activities.

Candidate’s Requirements

• University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or another relevant scientific discipline (Master's degree preferred).

• Minimum 7 years of experience in pharmaceutical Quality Assurance, Compliance, Supplier Quality, Manufacturing Quality, or related GxP functions.

• Demonstrated experience managing supplier qualification programs and conducting GMP/GDP audits as Lead Auditor.

• Strong knowledge of pharmaceutical development, manufacturing, packaging, testing, storage, and distribution activities.

• Excellent knowledge of relevant GMP/GDP regulations and international quality standards, including EU GMP, EU GDP, ICH, PIC/S, WHO, FDA, and ISO requirements.

• Proven ability to independently interpret regulations and implement pragmatic, risk-based compliance solutions.

• Experience in developing and managing Quality Agreements and external partner oversight programs.

• Strong project management skills with the ability to manage multiple priorities in a dynamic environment.

• Excellent analytical, organizational, and problem-solving capabilities.

• Confident, proactive, and capable of influencing stakeholders at all organizational levels.

• Strong interpersonal, communication, and leadership skills.

• Knowledge of other GxP areas such as Pharmacovigilance (GVP), Clinical Quality (GCP), Computerized Systems Validation (CSV), or Data Integrity requirements would be a strong advantage.

• Fluent in English; knowledge of another European language is considered an asset.