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Associate Director Quality Systems

Monte Rosa Therapeutics, Inc  –  Boston, MA
... Knowledge and experience of clinical and commercial systems supporting compliance with US and global regulations (FDA, EMA, ICH, etc.). GLP experience a plus. Able to provide solution-minded approach and flexibility to emerging challenges. Able to ... - May 29

Quality Control Technician

North Coast Seafoods  –  Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 02

Associate Director/Director, Regulatory Affairs, Advertising

Alkermes  –  Waltham, MA
... Communicates with FDA and contributes to health authority negotiations as necessary. This is a hybrid position, onsite at our Waltham, MA office. Key Responsibilities: Provide oversight and review of product and disease state education materials for ... - Jun 03

VP, Regulatory Affairs & Quality

Vigil Neuroscience, Inc.  –  Watertown, MA, 02472
... The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality ... - Jun 04

Quality Manager for High Complexity CLIA Lab

Nanobiosym  –  Cambridge, MA, 02142
... The position requires extensive cross-functional interaction throughout the organization, strong liaison activities with senior management, as well as with external notified bodies and third parties including CLIA, FDA and other global regulatory ... - Jun 12

Associate Director, Biostatistics

Sarepta Therapeutics  –  Cambridge, MA
... activities in support of IND/NDA/MAA or other regulatory submissions Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs Supports and contributes to the preparation ... - Jun 08

Senior Quality Assurance Manager

Planet Pharma  –  Waltham, MA
... • Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies. • Collaborate with internal and ... - May 23

Nurse Practitioner Physician Assistant

KSA Wellness Inc  –  Braintree, MA
... Obtains & reviews patient's medical history information relevant to patient care Conducts thorough physical examinations Orders & reviews laboratory studies as well as diagnostic procedures Assumes responsibility for prescribing FDA approved ... - Jun 08

Quality Control Manager

North Coast Seafoods  –  Boston, MA
... root cause analysis and corrective action Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party Sustain and improve ratings on annual certifications Performs other related duties as assigned ... - Jun 02

Global Regulatory Strategy Director

Aquinas Consulting  –  Boston, MA
... Representing company as point contact FDA and leading company delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, ... - Jun 11
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