Director,Quality Operations Support - Remote in ,

Date Posted: 06/30/2020

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Job Description


Director, Quality Operations Support
• REMOTE **This position can be remote or sit at any of our US sites** AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Director of Quality Operations Support is responsible to enable the BU VP of Quality Operations in delivering AMRI strategic objectives.  This position also enables the site Quality Heads in the effective implementation of AMRI global quality standards, global procedures and other AMRI strategic initiatives. This role will effectively collaborate with cross-functional technical and operational teams across the sites and global functions to monitor the progress of site Continuous Improvement Plans. Quality Operations Support Director is responsible for providing onsite support to BU sites for inspection readiness, managing day -to-day quality operations during inspections and as a subject matter expert for complex investigations. This role also requires serving as a delegate for BU VP of Quality Operations in customer meetings and other situations.  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. MAJOR DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.
• Key enabler for BU VP of Quality Operations and support as a chief of staff for the BU Quality leadership team in delivering key quality objectives and assist in the development of the Quality Operations global strategy.
• Responsible for leading the Business Unit Quality Management Reviews on a quarterly basis
• Key conduit between sites and customers for finalizing quality agreements to standardize the requirements across all sites
• Key point person to provide technical and quality support for the implementation of global standards andprocedures at the sites
• As a Chief of Staff this roles requires leading and managing Site Quality Leadership team meetings and follow up action plans
• Responsible to develop various training programs by collaborating with global compliance team
• Provide technical support required for the implementation of electronic systems such as DMS, LIMS at the sites
• Play a key role in the development of responses for major regulatory inspections at BU sites.
• Play a key role in the review of CIP programs developed by the sites and also in the review and prioritization of CAPEX projects
• Responsible for monitoring GMP intelligence for emerging regulations, inspectional hot topics and to support the sites in meeting the requirements
• Readily available to travel to the sites as needed, especially during inspection readiness and during inspections.


QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience
• Minimum B.S degree in Life Sciences . 
• At least fifteen years of experience in the pharmaceutical industry, with at least 8 of those years being experience in Quality Assurance and at least 3 of supervisory experience.
• Strong knowledge of the pharmaceutical industry regulations applicable to API, Drug Product and Vaccine manufacturers. 
• Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal.
• Strategic thinking.
• Willingness to travel globally up to 30
(plus or minus 10% depending on current situation)

Job: Quality
Primary Location: ,
Other Locations: Burlington, Massachusetts
Schedule: Full-time
Job Posting: 06/30/2020
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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