AMRI Associate Director, Quality Assurance in Burlington, Massachusetts
The Associate Director, QA reports directly to the Director of Quality to ensure compliant cGMP operations are continuously maintained across the site. Responsibilities include direct supervision of the quality operations unit charged with the review and management of departure investigations (i.e.,root cause, product impact and CAPA), GMP document review, batch disposition, and executing AMRl's internal audit program. The incumbent will also play a vital role during regulatory agency audits. The Associate Director, QA will interact with AMRI customers through routine production activities as well as via the support of clientaudits.
/Other duties may be assigned/
· Establish and maintain a risk-based and scientific-based quality system to protect the public health and to meet AMRl's business needs.
· Through a quality system approach, ensure all GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
· Provide quality oversight and review to AMRl's validation program including process validation, cleaning validation, computer software validation, and instrument qualification.
· Provide leadership and management within the department through a structured process of objective setting, performance appraisal, and individual development. By improving individual performance and group collaboration, the Director will be responsible for improving the overall department productivity and efficiency.
· Oversee the site's quality assurance program. This includes overseeing and assisting with the site's training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records.
· Along with the QA staff, be responsible for the release or rejection of GMP materials.
· Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function
· Support onsite inspection by regulatory agencies and customers.
· Identify and lead operational excellence initiatives, both in the department and companywide.
· Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
· Through a robust supplier qualification program, ensure audit(s) of vendor manufacturing facilities, customers and outside contract organizations are in compliance with internal procedures and regulatory requirements. Ensure AMRI maintains an Approved Supplier List.
Education:Bachelor’s degree in Microbiology, Chemistry, or related field required; advanced degree preferred
Relevant Work Experience: 8-10 years’ of QA and/or QC experience in drug substance or drug product manufacturing with a minimum of 3 years in a management role. Professional background not directly related to QA/QC functions will also be considered given relevant technical background and understanding of cGMP’s.
At least 5 years’ of experience in aseptic fill/finish and sterility assurance programs
Knowledge, Skills & Abilities:
· Leadership experience required
· Solid knowledge in FDA regulations, especially the cGMP for the 21stcentury initiatives as well as global GMP
· Excellent communication skills
Organization: *AMRI Burlington
Title: Associate Director, Quality Assurance
Requisition ID: 1000874
EOE Protected Veterans/Disability