3633 Technical Manager, Clinical QA
Job Description:Create, revise and approve the company’s Phase Appropriate Quality Systems documentation.Represent Clinical Quality Department in cross functions forums.Draft and approval of Quality Technical Agreements with CDMOs as required for internal support.Provide quality oversight for internally manufactured early-stage products and starting materials.Provide support to audits and inspections of CDMOs and […]
0100 Quality Technical Manager
Description:The Company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.These conditions are often inherited, difficult to diagnose, progressively […]
0424 Specialist, QA Operations
Duties:This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in manufacturing facilities. The responsibilities in the role include the following:Provide quality oversight of one or more portions of […]
5099 Quality Engineer II
Main Purpose of the Position:Provide technical review and approve validation deliverables ensuring proper study design and execution.Maintain the compliance status of the assigned validation areas at a state of inspection readiness.Working with multiple functions, lead solution of validation issues following cGMP regulations and company standards.Site Quality technical and regulatory subject […]
Quality Assurance Specialist II
Job Responsibilities:Perform detailed/final review of manufacturing batch records for manufactured cell banks, clinical drug substance, drug product and final drug product, and large and small molecule finished goods for global IMP/Clinic/Market use.As needed, provide Quality support and oversight of manufacturing activities for large molecule and small molecule.Compile Batch History Records […]
5999 Engineer 2 Global QA CSA
Duties:Provide CSQA expertise and oversight of QC/BAS Analytical Instrument, Enterprise, Operations/Supply Chain and Quality computerized system validation from a quality assurance perspective to ensure quality and compliance requirements are met.Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems […]