About Idorsia Pharmaceuticals Ltd
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.
We are looking for a QA Manager GMP/GDP to join our team!
Job Responsibilities
- Provide GMP/GDP quality assurance expertise during development and commercialization of Idorsia’s products
- Ensure all required quality activities are initiated and completed according to the development stage
- Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
- For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
- Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
- Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
- Notify CMC team and management of potential quality, regulatory and lead time issues
- Participate, represent and defend quality activities in CMC team meetings
- Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
- Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation
- Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators
- Release of DS and DP Bulk as defined in the relevant release SOPs
Candidate Requirements
- University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
- 3-6 years of experience in different positions like pharmaceutical product development/ quality control / analytical development / chemical production or similar operational positions in the pharmaceutical industry
- 3-6 years of experience in quality assurance of drug substance and/or drug product
- Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
- Good knowledge of (c)GMP/GDP’s
- Ability to interpret and implement Quality standards
- Ability to manage complex projects and prioritize workload according to the project importance
- Ability to pro-actively initiate and lead quality activities
- Ability to manage multiple tasks with competing priorities
- Good interpersonal and influencing skills
- Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
- Ability to communicate clearly and professionally both verbally and in writing
- Fluent in English and at least basic knowledge of an additional language, German or French advantageous
Work Location: Allschwil
Country: Switzerland
Business Area: Global Quality Management - Quality Operations
Schedule: Fulltime
Job Type: Permanent
Job ID: 4612
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.
