Head, Quality Compliance and QMS

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Amylyx Pharmaceuticals offers a unique opportunity to be part of a team that is truly building a company from the ground up!--Currently under 25 FTEs, you will play a key role in both launching a new drug for ALS and launching a company that has potential to shape the way medicines are created in the Cambridge (and beyond) biotech community.--Together, with our growing leadership team of industry veterans, we relentlessly drive forward to help patients and refuse to accept the standard approach.Amylyx Pharmaceuticals was started in 2013 by 2 students at Brown University.--The company remains founder lead with a strong entrepreneurial culture. Today we are a clinical-stage pharmaceutical company developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease and other neurodegenerative diseases. AMX0035 is a first-in-class investigational therapy designed to reduce neuronal death and dysfunction. AMX0035 targets mitochondrial and endoplasmic reticulum-dependent neuronal degeneration pathways.--In recently announced results from the CENTAUR study, Amylyx' first in class investigational therapy, AMX0035, demonstrated a significant treatment benefit for people with ALS. These results mark a significant step forward in the fight to develop new treatments for ALS. In June we announced enrollment of our phase II PEGASUS trial assessing AMX0035 in Alzheimer's disease.In September phase 2 ALS clinical data were published in the New England Journal of Medicine.In October, ALS survival data were published in the journal Muscle and Nerve.With these results, Amylyx now has a responsibility to move ahead as efficiently as possible, as people living with ALS do not have time to wait.--We are bringing together a team dedicated to fearless innovation, and who believe together we can achieve our goal of helping patients.Amylyx is seeking a Head, Quality Compliance and QMS who will be responsible for developing, maintaining, and executing Quality Management Systems (QMS) and processes to ensure GxP compliance. We are looking for a hands-on individual that can partner with internal departments to develop and support the Documentation Management System (DMS), Learning Management System (LMS) and Quality Management System (QMS) process improvement implementations that meet business and regulatory requirements. The individual will lead inspection readiness activities to assure Amylyx is inspection ready at all times. The individual will also be responsible for supplier oversite and audit execution.Responsibilities include:* Assist in document management system configuration and implementation* Lead GxP SOP generation, review, and approval process.* Support cross functional teams in processing document requests, document approval, and document archival.* Maintain periodic review process for documents.* Manage and oversee GxP training program. Works with functional area managers to establish training matrixes, assigns training and reports training KPIs.* Implement and manage QMS for deviations, CAPA and Change Control. Monitor the overall health of the QMS, reports QMS KPI to executive team and drives continuous improvement of the QMS.* Create and revise SOPs related to document control, document archival, training and QMS.-- Support the preparation for and hosting of regulatory agency inspections.* Manage the regulatory inspection process, to include back room and front room communications, SME assignments, and mobilization planning.* Support inspection readiness activities throughout the organization.* Develop GxP audit plan per internal procedures.* Execute internal and external audits, according to an approved audit schedule; negotiate audit date, prepare, and send agenda to auditees.* Write audit reports and observations letters, issue audit follow-up documents in a timely manner. Track open observations to closure.* Evaluate auditee's responses, communicate on compliance issues and corrective actions identified from the audits.* Determine and document decisions on vendor qualification status, escalate critical findings to senior management.* Write, revise, and review procedures for the supplier management program.* Maintain and update the approved vendor list.* Support Quality Operations activities, as required.* Promote a Culture of Quality.QUALIFICATIONS* BS degree with a minimum of 10 years of experience in Biotech or Pharma and 5+ years' experience in Quality Systems and compliance roles. A degree in life sciences or Chemistry a plus.* Ability to develop and implement appropriate GxP quality systems to ensure site compliance and Sponsor oversight responsibilities.* Knowledge of FDA and EU GxP requirements--as applicable to clinical trials, manufacturing, testing, packaging, and distribution.* Experience with vendor qualification, vendor oversite and GxP audit execution.* Working knowledge of QMS electronic platforms e.g. Veeva, Pilgrim, TrackWise, ZenQMS, etc.* Experience in preparing for and supporting inspections by regulatory agencies.* Understanding of domestic and international regulatory requirements.* Ability to effectively prioritize and manage multiple projects and tasks in a fast-paced environment.* Outstanding communication skills (verbal and written)* Ability to travel and conduct vendor audits as needed (domestic and international)Amylyx offers competitive compensation including pre-IPO stock options. Our comprehensive benefits package includes self-managed time off, medical, dental, vision, life insurance and a health savings account.--We offer flexible work options, commuter benefits and/or free parking near our office in Cambridge.

Keywords: Amylyx Pharmaceuticals, Cambridge , Head, Quality Compliance and QMS, Other , Cambridge, Massachusetts