Associate Director (07-1-2040-11B)

Associate Director (07-1-2040-11B) Department/Division: Quality Assurance/Safety Job Type: Full Time, Employee Company: Vertex Pharmaceuticals Inc. Location: US-MA-Boston Job Reference Id: 548   Description: The purpose of this position is to serve as a key and critical GMP team member for the Vertex Product Dispositon function. This individual will be responsible for Batch Disposition; Deviation, Investigation and Corrective Action; Technical Complaints; Oversight of Validation activities at Vertex CMOs; internal oversight of the Pharmaceutical Development organization and external support for all Vertex Contract Manufacturing Organizations that manufacture Clinical Trial Materials.. Candidates for this position must have excellent knowledge in cGMP regulations, ICH and other relevant regulations and guidance associated with the manufacture of API and Drug Product. Responsibilities of the position: Develop and Maintain a robust Quality Assurance Program covering Batch Disposition; Deviation, Investigation and Corrective Action. Develop and Maintain SOPs that support QA responsibilities in conjunction with product integrity for internal Vertex activities in the Quality Assurance Department and support the same activities in the Pharmaceutical Development organization. Provide quality oversight to the Vertex QA and Pharmaceutical Development by: Approving all procedures Overseeing GMP readiness Develop a system for management of Product Technical Complaints Develop a process for Product Annual Review. Provide oversight of Validation activities at Vertex Contract Manufacturing Organizations; maintain applicable documents associated with Validation of Vertex products. Provide Quality oversight at Vertex CMO's Relationship management with internal Vertex customers and Vertex CMO's Provide GMP training to internal Vertex customers when requested. Minimum Education Requirements: Bachelor's Degree The successful candidate for this position will have an undergraduate education in basic or applied science (chemistry, biological sciences, pharmacology, pharmaceutical science). A practical working knowledge of computers and data management is necessary. Additional advanced training in areas of pharmaceutical industry-related practices, 21 CFR Part II, and GMPs are important. Apply Now