Senior GMP QA Manager 80-100

Alentis Therapeutics the Claudin1 Company is on a mission to treat cancer and reverse fibrosis. To this end we are rapidly advancing a clinical pipeline of antiClaudin1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin1 and bringing muchneeded medicines to patients suffering from solid tumors as well as kidney liver and lung fibrosis.

Tasks

• The GMP QA Manager is responsible for strategic and operational management of quality activities related to the manufacturing release and distribution of biologics (mAbs ADCs etc.).
• The scope of this role includes the management of the GMP QA activities (as detailed below) at Alentis Therapeutics the qualification of the contracted vendors through audits to ensure that they are compliant with global regulations the implementation of appropriate processes to protect product quality and the maintenance of QMS documents and internal quality records.

Quality Management Systems and general QA responsibilities

• Management and maintenance of QMS documents within GMP area
• Keep Head QA informed about the GMP QA related activities and issues
• Evaluation of new regulations impacting the need for new SOPs and/or revision of existing SOPs within area
• Keep management informed of GMP QMS status
• Organization and conduct of GMPrelated trainings (e.g. SOPs)
• Preparation conduct of selfinspections and reporting of results
• Organization Followup and participation of authority inspections
• Provide input to annual audit plan within GMP area
• Ensure adherence to annual audit plan within GMP area

Operational Quality Assurance responsibilities

• Regular meetings with CMC team to discuss any impact on the QMS related to CMC strategy and operational activities
• Work in conjunction with CMC team to ensure analysis and followup on GMP QA aspects
• Assure that the potential risks are appropriately addressed and mitigated if applicable
• Lead quality investigations including input and approval of plans for resolution of GMP/GDP issues such as deviations CAPA implementation change controls complaints and distribution
• Review cGMP batch manufacturing and packaging records and provide recommendations for approval/rejection and disposition
• Lead and coordinate the QP Release Process setup (including communication and alignment with external QPs implementation of QPQP agreements if required) and Sponsor Release process to ensure timely disposition of finished labelled supplies
• Responsible for qualityrelated activities and requirements to enable release of raw materials drug substance drug product and finished IMP
• Liaise with Program Management and Clinical Team to ensure transparency of clinical timelines and project goals (e.g. FPI)

Third Party Quality Assurance responsibilities

• Performance of qualification/technical visits at vendor sites in order to support the appropriate vendor selection and supplier qualification
• Support contracting of CDMOs
• Review approve and oversee Quality Agreements with CMOs
• Organisation conduct and documentation of audits at vendors service providers and collaboration partners including followup (CAPA management)
• Ensure documentation is maintained by the CMOs and internal quality records are regularly updated
• Take responsibility for a timely QP release performed by external QP

Communication

• Provide clear direct and timely verbal and written communication to stakeholders (CMC Clinical Team Management)
• Provide guidance and advice to CMC Clinical and Regulatory teams with respect to QP Release of clinical products
• Liaise with Program Management and Clinical Team to be fully on top of clinical timelines and project goals (FPI etc)s implementation

Requirements

• Experience of > 5 years involved in pharmaceutical (investigational medicinal products) Quality Assurance
• Extensive experience and knowledge of GMP/GDP with at least 3 years in biologics (MAbs ADCs) support
• Knowledge and understanding of US EMA and ICH regulations and industry standard for GLP and GCP as well as other company related regulatory requirements
• Thorough understanding of the drug development process experience with biologics is a requirement
• Proactive and take leadership
• Experience with eQMS systems but also willing to work paperbased for standard QA tasks
• Able to work both independently and as a team player
• At least 3 years of auditing experience in GMP/GDP area and qualified as independent / lead auditor
• Ability to Travel internationally / worldwide
• Relevant working/residency permit or Swiss/EUCitizenship required

Benefits

We offer a competitive salary and opportunities for career growth and development.

Work place could be Basel or Geneva