Head, Quality Compliance and QMS
Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: February 25, 2021
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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
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