Director, Global Quality Systems & Business Process Owner in Waltham, MA

Date Posted: 07/06/2020

Job Snapshot

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    Waltham, MA
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Job Description


AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.  The Director, Global Quality Systems and Business Process Owner (BPO) is an integral part of the AMRI team, contributing to our success by being responsible for the leadership and progression of strategic projects to support implementation and maintenance of the Global Quality System for all GxP elements of the business. The role includes design and development, and/ or refinement of a Global Quality System that aligns with ICH Q10 and all applicable regulatory guidances. Leadership experience, functional and cross functional, are critical to the successful execution of the roles and responsibilities of the BPO.
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.
• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems
• Partner with BU’s/ sites to generate Monthly and Quarterly Metrics for periodic Quality Management reviews
• Lead and facilitate Quality Management Review meetings
• Identify and lead Quality Systems improvement initiatives by working closely with Global/ BU Quality departments and other key stakeholders
• Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
• Lead/ partner with IT on the selection and implementation of IT solutions in alignment with the Global Quality and Quality systems strategy
• Provide leadership to ensure all documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory compliance requirements.  Also, ensure that documentation aligns with global document hierarchy as defined within the Quality System
• Identify, define and lead quality initiatives and engineering projects to improve Quality Systems, product quality and process capability
• Collaborate with Training Team to ensure training curricula are current and accurate
• Lead cross-functional teams to complete projects, address quality issues and implement Quality System improvements
• Monitors Quality Systems for trends and notify management of events requiring immediate action
• Identify compliance gaps and lead focused teams to resolve compliance issues
• Lead department projects of varying complexity
• Manage the development, monitoring and maintenance of GMP/QSR standards and processes to ensure compliance with local and federal regulations
• Interact and influencepeers to ensure compliance with internal SOPs and FDA regulations
• Maintain current knowledge of GMP Compliance program and of applicable company standard operating procedures 
• Provide guidance on interpretation and application of specified QA/GMP compliance regulations, e.g., 21 CFR Part 11/210/211
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Interface with regulatory agencies and participate in compliance audits as required


• Bachelor’s Degree in Business or Life Sciences with 12 years of Quality experience in the pharmaceutical and/or medical device industry
• Experience in Quality Systems, and international regulatory requirements and guidances
• Experience with face to face interaction with FDA and international regulatory agencies
• Demonstrated leadership experience, both functional and cross functional (e.g., project management, cross functional teams)
• In-depth knowledge of regulatory requirements (e.g., 21 CFR Parts 11, 210, 211, 820; EU GMPs)
• Excellent analytical, problem solving, and troubleshooting skills
• Experience in IT solutions, e.g., document management, training, deviations, CAPA, change control, LIMS
• Strong interpersonal and communication skills
• Ability to work in a team environment
• Ability to multi-task
• Strong change management/implementation expertise and experience
• Excellent verbal andwritten communication skills
• Ability to partner with business peers and senior leaders

• Advanced degree desired in science or engineering
• Lean Six Sigma certification (green or black belt) desired
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: Waltham, Massachusetts
Schedule: Full-time
Job Posting: 07/06/2020
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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