Job details
Job type full-time
Full job description
Founded in lyon, france in 2004, erytech pharma incIs a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseasesLeveraging its proprietary erycaps platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, erytech has developed a pipeline of product candidates targeting markets with high unmet medical needsErytech`s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
Erytech has openings for an experienced manager - clinical quality assuranceThis role can be based remotely on the east coast in est, in the boston, ma area or at our brand-new manufacturing facility located at 104 campus drive in princeton, nj.
Reporting to the chief medical officer, this role will manage the gcp compliance department and lead gcp/gvp compliance activities within the companyThis position will oversee the quality documentation system, supplier and site quality management, gcp/gvp training programs and ensure cross-functional interactions with other departments with a `quality` mindset.
Primary responsibilities:
Quality documentation system:
Drive the creation and implementation of quality standards, standard operating procedures and guidelines to ensure gcp/gvp compliance.
Assist in the implementation of new processes
Supplier control:
Participate in the evaluation and selection of clinical / pv contractors
Interact with relevant erytech departments, external suppliers, cro management on gcp / gvp quality issues, including preparation of quality agreements
Design and maintain the external audit plan
Conduct external audits to assess compliance with gcp requirements, investigation plans and erytech standards for clinical trial activities as per audit plan.
Investigator site compliance:
Oversee the management of site audits and capas.
Evaluate the effectiveness of capas
Training management:
Lead the development of gcp training programs.
Oversee the proper delivery of training and maintenance of training records.
People management:
Management of the team (2 direct reports located in lyon, france).
Quality control process:
Oversee the `quality control` process.
Quality and compliance:
Design study quality plans in collaboration with the clinical operations team.
Coordinate and support the clinical development team in the development of effective capas.
Approve impact analysis and action plans for the change control process within the clinical development department.
Perform regulatory oversight of changes in industry and regulatory standards regarding gcp requirements.
Be the point of contact in the clinical quality department for product complaints.
Oversee the capa / deviations system.
Set up quality indicators for the comex
Spirit of quality:
Provide guidance to erytech teams on the interpretation and application of gcp regulations.
Participate in quality improvement initiatives
Inspections:
Lead the management of gcp inspections by clinical study regulatory agencies at erytech, clinical sites and providers.
Coordinate follow-up actions according to established timelines.
Provide responses to any issues raised during inspections.
Lead the inspection readiness program within the clinical development department.
Qualifications:
Bachelor degree in biology / science / health / or a related field
At least 10 years in a clinical quality assurance department (cro, pharma, consulting)
Knowledge and mastery of gcp / gvp in an international context
Project management
Quality management
Fluent english
Leadership and strong communication skills
Team spirit
Analytical and methodical skills
Up to 20% travel.
Possibility of flex office.
Note: this description is standard and only mentions the main elements, competences and missions of the job positionIt is not all-comprehensive and may evolve depending on the company’s needs.
