Senior QA Compliance & Auditing Manager (GMP/GDP)

Job description

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. Work Location: Allschwil, Switzerland Business Area: Technical Operations - Global Quality Management - Compliance & Auditing Job Type: Permanent, full time Job ID : 4807 At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success. We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees. Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course. Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.