Manager, Quality Assurance in Burlington, MA

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Job Description


Manager, Quality Assurance in Burlington, MA
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Manager, Quality Assurance reports directly to the Associate Director, Quality Assurance 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 deviation investigations, GMP document review, on-floor batch review, batch disposition, and executing AMRl's internal audit program. The incumbent will also play a vital role during regulatory agency audits and interact with AMRI customers through routine production activities as well as via the support of client audits.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities

• 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
• Establish and maintain a risk-based and scientific-based quality system to protect the public health and to meet AMRl's business needs
• Provide leadership and management within the department through a structured process of objective setting, performance appraisal, and individual development
• Drive product disposition timelines by ensuring batch record review cycle times are met
• Oversee the site's quality assurance program including overseeing and assisting with the site's training programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records
• 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
• Assist the QA compliance groups to maintain the ongoing supplier qualification program, and internal audit program
• Populate and monitor KPI metrics
• Liaise with clients as needed


• Bachelor’s Degree in Microbiology, Chemistry, Biology, Engineering or related field required; advanced degree preferred
• 8+ years of QA experience in drug substance or drug product manufacturing
• Leadership experience strongly preferred
• Solid knowledge in FDA regulations
• Strong knowledge in the application of phase appropriate, risk based principles
• Ability to perform in a fast paced, dynamic environment
• Strong root cause analysis/problem solving skills
• Strong critical thinking capacity
• Proficient in TrackWise/TrackWise Digital
All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Job: Quality
Primary Location: Burlington, MA
Schedule: Full time
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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