Lead, Gvp Quality Assurance

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:

• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• AMX0035 is currently under review with the European Medicines Agency

Position Summary
The Lead, Good Pharmacovigilance Practice (GVP) Quality Assurance (QA) oversees the aspects of GVP QA activities internally at Amylyx and supports activities contracted to Contract Research Organization (CRO) and GVP vendors. This role is responsible for leading or providing QA oversight of GVP activities for pre- and post-marketed products. This role is responsible for managing cross functional relationships with internal and external stakeholders.
Responsibilities

• Partner with Amylyx clinical and commercial stakeholders to drive compliance with pharmacovigilance regulations to maintain alignment with Amylyx systems and standards
• Proactively provide GVP support for clinical and commercial activities to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems
• Lead the development and support the execution of risk-based QA GVP programs
• Lead health authority inspection and inspection preparation activities
• Support training GVP activities for business groups, if needed
• Support development of the SOPs related to GVP activities according to applicable global (ICH) and local standards and regulations
• Support other GxP areas including GMP, GCLP and GCP
• Lead Quality Audit Management for internal and external GVP audits and other GxP areas as needed

Requirements

• Working knowledge of international GxP guidelines (ICH) and directives, international regulatory standards, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA)
• 8+ years GVP quality or compliance related discipline or equivalent quality management activities
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
• Ability to travel about 20%
• Strong strategic and critical thinking skills
• At least 8 years pharmaceutical or biotechnological drug development experience
• Must be willing and able to be onsite at the Company’s office for employee orientation, meetings, and as otherwise required
• Bachelor’s degree or equivalent professional experience in nursing, pharmacy, medical technology discipline

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.