Senior QA Compliance & Auditing Manager (GMP/GDP) — Idorsia Pharmaceuticals
- Location
- Allschwil
- Contract
- full-time
- Posted
- 40 days ago
Role overview
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 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.
- 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:
Main responsibilities
- 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.
Application process
- 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.
Contacts
- 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.
Company and context
- 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.
Additional details
- 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:
- Travel domestically and internationally as required to support supplier qualifications and audit activities. Candidate’s Requirements
- 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
Notes and original content
- 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:
- Travel domestically and internationally as required to support supplier qualifications and audit activities.
- Candidate’s Requirements
- 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
Questions about this listing
What salary does Idorsia Pharmaceuticals offer for this role?
Idorsia Pharmaceuticals lists CHF 85'500 - 129'500 gross per year for this position in Allschwil. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Idorsia Pharmaceuticals offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Idorsia Pharmaceuticals during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Idorsia Pharmaceuticals?
Use the "Apply now" button on this page — it links directly to Idorsia Pharmaceuticals's original listing at careers.idorsia.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
