Manager QA and Regulatory Compliance Basel, Switzerland | Full-Time | Permanent
Vor 5 Tagen
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Who we areVectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology, and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliverWe focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs. By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
Role PurposeWe are seeking a Manager QA and Regulatory Compliance. You will oversee all aspects of quality for our Singapore laboratories. This role involves defining and monitoring the risk-based quality strategy and programme, ensuring compliance with OECD GLP, ISO 17025, and other applicable guidelines.
Key Responsibilities- Define and monitor the QA programme, including verification of non-clinical study plans and QA inspections.
- Manage compliance strategies, external audits, regulatory inspections, and quality oversight of non-clinical studies.
- Oversee the expansion and implementation of the QMS at global and local levels.
- Lead and develop the QA team, providing ongoing training and education.
- Act as lead QA for the facility, ensuring conformance with GLP principles.
- Provide oversight for GLP studies and ISO 17025 accredited methods.
- Manage QA process workflows, QMS implementation, and GLP compliance training.
- Oversee the facility's NC & CAPA reporting programme and monitor quality KPIs.
- Collaborate across departments to achieve quality targets and foster a quality mindset.
- Bachelor's degree in a scientific discipline, MS or equivalent preferred.
- Demonstrable related experience in a pharmaceutical/biologics/biotechnology company.
- More than 10 years of ISO, GLP, or GxP working experience.
- Knowledge of regulatory requirements, GLP, FDA, ICH, GCP, GxP, and industry practices.
- Advanced knowledge of OECD GLP principles and other quality systems.
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees. Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
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