GRANITE BIO is a private biotechnology company located in Basel (Switzerland). Supported by top‑tier investors with ~$100M raised to date, GRANITE BIO pursues a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Our programs are first‑in‑class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT‑001, the lead asset, depletes inflammatory monocytes and has completed a Phase 1a trial with favorable safety and pharmacodynamic effect. GRT‑002 is an IL‑3 neutralising antibody that may play a key role in type II inflammation.
We foster an open, interdisciplinary, diverse, and creative working environment that supports work‑from‑home options where appropriate. The successful candidate will be highly motivated, enthusiastic, detail‑oriented, innovative, and possess strong organisational and communication skills.
Responsibilities
* Implement and maintain a quality management system aligned with GMP, ICH GCP, and industry standards.
* Act as GMP Quality representative in collaborations with CDMOs and other stakeholders, covering QA and QC.
* Lead interaction with GCP QA third‑party vendors for GCP QA operations.
* Develop and maintain a suitable quality strategy and standards for the growing organisation.
* Generate and maintain essential quality documents (SOPs) ensuring compliance.
* Develop and implement training programmes for QA system requirements and train all staff.
* Represent QA in internal and external teams (clinical trials, CDMO/CRO interactions) and ensure procedural compliance.
* Prepare and support vendor qualification, including audit planning and execution.
* Provide guidance for the supply chain and release processes of clinical phase products.
* Conduct internal and external audits to ensure regulatory compliance.
* Establish a system to evaluate, manage, and maintain qualified suppliers such as CDMOs and CROs.
* Collaborate with senior management to implement process improvements that enhance the efficiency of R&D operations.
* Represent the organisation in regulatory inspections and audits.
Qualifications
* 15+ years of experience in QA within GMP biopharmaceutical manufacturing, with strong hands‑on knowledge of GCP.
* Sound understanding of biologics manufacturing and quality control for large molecules.
* Ability to design practical GxP QA approaches in a development‑focused start‑up environment.
* Hands‑on experience with internal and/or external audits at CDMOs and CROs.
* Experience in achieving inspection readiness and participating in inspections.
* Knowledge of electronic document or QA systems.
* Team player with a resourceful, fast‑learning mindset.
* Excellent communication and interpersonal skills.
* Experience working in an international business environment.
* Fluency in English (mandatory).
Benefits
* Well‑equipped laboratories and offices at the Tech Park in Basel.
* Commuter benefits, including parking or commuter contribution.
* Flexible working arrangements.
* Annual holidays plus office/lab closure between Christmas and New Year.
* Birthday off – one day off for your birthday.
* Subsidised meals and free coffee.
* Support for individual employee development.
* Innovative and creative working environment.
* International, diverse and passionate team.
* Regular off‑site team events.
To apply, please send your CV and cover letter using the application form.
Seniority level
Director
Employment type
Full‑time
Job function
Quality Assurance
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