Associate Director Quality Assurance GMP
vor 1 Woche
Associate Director Quality Assurance GMP
To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines. In this role, you will be responsible for Molecular Partners' QA activities in GMP. As Associate Director Quality Assurance, you report to the Head of Quality Assurance. You are part of an interdisciplinary QA team covering GXP, Records Management and IT Compliance and you are working closely with our CMC team responsible for the manufacturing of our products.
This challenging and diverse position will include the following tasks and responsibilities:
- Involved in release, approval activities and GMP documentation reviews;
- Qualification and management of CDMOs;
- Tracking, assessing and follow-up non-conformities and CAPAs;
- Monitoring of trends and changes with regard to regulations, guidelines, and identification of areas for improvement to ensure an efficient quality management system in compliance with GXP requirements;
- Liaise and support other departments in quality relevant activities;
- Support of the setup of internal audit programs;
- Preparation, conduct/host and follow-up of internal audits;
- Participation at and performing of risk management activities;
- Participation in the preparation, hosting and follow-up of regulatory inspections;
- Conduct of training for employees involved in GXP-related activities;
- Support of Records Management and IT compliance in the development and set-up of documentation, processes and maintenance of the eDMS.
For this position, we are looking for an enthusiastic and highly skilled individual who features the following credentials:
- Degree (MSc or PhD) in Life Sciences or related discipline such as biochemistry, biotechnology, pharmacy, chemistry;
- At least –5 - 10 years working experience in the pharmaceutical industry and 5 years in quality assurance positions;
- Demonstrated expertise in GMP QA systems and operations;
- Solid understanding of manufacturing operations across the biotechnology space, including aseptic processing (development, manufacturing, analytics);
- Experience in product development is an asset;
- Experience with radiopharmaceuticals is an asset;
- Experience in leading teams and providing training;
- Auditing experience;
- Excellent team player with cultural awareness and sensitivity, with strong project management skills and able to work in a matrix organization, with a hands-on attitude;
- Open-minded, creative, self-motivated and dynamic personality and eager to learn and develop with the company;
- Familiar with MS-Office programs and SharePoint;
- Solid knowledge of English and German is mandatory.
Please note, that applications will only be reviewed in the week of June 9th.
Our offerPartnership and collaboration are at the core of our company, our research activities and our product candidates. Molecular Partners offers an international working environment and the opportunity to collaborate with outstanding individuals from numerous disciplines, who contribute to our shared goals of scientific excellence, respectful teamwork and personal aspiration. We foster true innovation and creative thinking to advance our therapeutic product candidates and continue to be inspired by the difference we can make for our patients. At Molecular Partners you will discover a challenging job, inspiring colleagues and a true purpose. If you are interested in working at Molecular Partners, we are looking forward to hearing from you Please submit your detailed curriculum vitae via our career portal.
We only accept online applications.
Job locationPreferred head hunter clausePlease note Molecular Partners AG operates a list of preferred recruitment partners. For those partners who have no valid, signed agreement in place with Molecular Partners AG, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Molecular Partners AG (including any of its subsidiaries, affiliates or related companies) are not subject to payment of any form of introduction, placement or referral fees.
General informationReference Reference Information about Molecular Partners AGFounded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 200 highly qualified employees. In order to advance modern medicine and significantly improve the management of serious diseases, we have developed and successfully established a powerful new class of potent, specific and versatile small protein therapies, called DARPin therapeutics. The continuous development of a broad portfolio of therapeutic product candidates in oncology, virology and ophthalmology based on the company's proprietary DARPin platform allowed a successful listing of the company on the SIX Swiss Exchange and Nasdaq (ticker: MOLN). Next to our own pipeline of drug candidates we have entered into collaborations with leading international pharmaceutical companies, including AbbVie, Amgen and Novartis. The highly dedicated, multi-disciplined team at MP is committed to developing breakthrough medicines for serious diseases.
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