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Quality and Supply Chain Manager
3 weeks ago
**Quality and Supply Chain Manager**
Nuevocor is a pre-clinical stage biopharmaceutical company dedicated to developing genetic medicines to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its pipeline of programs to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac mechanobiology, to discover and develop therapies for multiple cardiomyopathies.
**Responsibilities**
- Implement, manage and maintain a compliant GxP Quality Management System, encompassing the aspects of Quality Risk Management, CAPA, Deviations, Change Control, Quality Documentation.
- Conduct internal and external audits, including at sub-contractor facilities and processes.
- Provide on-site support at CDMOs for manufacturing production.
- Manage supply chain of materials across sites of CDMOs, CROs and clinical trial sites.
- Prepare Quality documentation and agreements.
- Review GxP protocols, reports and Standard Operating Procedures to ensure compliance.
- Develop and deploy the GxP quality assurance strategy as approved by senior management.
- Reports all critical and relevant quality and compliance issues to management.
- Ensures quality assurance expertise is available and effective for GxP operations.
- Provide Quality Assurance review and disposition of GxP products, as appropriate.
- Acting as a point of contact with regulatory authorities.
- Support the development and harmonization of quality standards and processes.
- Maintain good relationships with regulatory agencies.
- Ensure that all personnel training, investigations, actions, CAPAs are completed on time.
- Assists in the development and maintenance of training program.
- Lead and assist in the development of SOP and procedures to support GxP functions.
**Requirements**:
- Scientific degree in Pharmaceutical Sciences or related fields.
- 5-10 years experience in GxP particularly GCP and GMP areas and other regulations applicable in the Pharmaceutical Industry.
- Experience with supply chain and shipping, preferably with biologics materials.
- Knowledge of drug development regulations and implementing GxP in Gene Therapies
- Actively able to manage multiple projects to meet timelines, while maintaining compliance.
- Ability to work in teams with diverse cultural and professional backgrounds
- High standards in documentation and record keeping.
- Strong interpersonal and organizational skills
- Strong collaboration and team working skills
- Excellent writing and verbal communication skills
- Excellent problem solving ability
- Ability to multitask
- Possess a mindset of no job too big or too small
Nuevocor is an equal opportunity and equal benefits employer. All qualified applicants will receive consideration for employment. Position is commensurate with experience.
