Head, Audit Management
Company: Amylyx Pharmaceuticals
Posted on: February 19, 2021
Amylyx is a Cambridge-based pharmaceutical company dedicated to
the development of therapeutics for the treatment of
neurodegenerative disorders. Guided by our core values, we
incorporate unconventional approaches through strong partnerships
with industry leaders, scientists, doctors and organizations. We
work collaboratively across everything we do to positively impact
the lives of patients and their families. "Why do neurons die?"
Those four words, asked in a dorm room at Brown University in 2013,
launched Amylyx into existence and began our journey to develop a
novel therapeutic for Amyotrophic Lateral Sclerosis (ALS),
Alzheimer's disease and other neurodegenerative diseases.
After methodically poring over an endless supply of scientific
literature, founders Josh Cohen and Justin Klee decided the best
way to prevent degradation in these diseases was to focus on
preserving neurons. What started as a question became a clinical
reality: Amylyx has since advanced its oral drug candidate,
AMX0035, into clinical trials in ALS (CENTAUR; trial completed) and
Alzheimer's disease (PEGASUS; fully enrolled).
Every day at Amylyx we're working to turn neurodegenerative
diseases from rapidly progressing conditions into ones that can be
managed medically. Together we can rewrite what's possible.
Amylyx offers a comprehensive benefits package including healthcare
coverage, flexible work options, discretionary time off, and
pre-IPO stock options.
This newly created position will be a key member the Quality
Leadership Team. The Head of Audit Management is accountable for
leading the risk-based vendor management program for Amylyx GxP
Quality, and for presenting the program during regulatory
inspections. The individual is responsible for planning,
conducting, and closing GxP vendor audits to assess Amylyx's
vendors and clinical sites level of compliance with GxP
regulations, guidelines, internal procedures, and industry
best-practices. In this role you will act as the primary contact
point for all audit related communication with vendors. You will be
responsible for maintaining approved vendor list and implementation
of Quality Technical Agreements. RESPONSIBILITIES:
- Develop yearly audit plan per internal procedures and manage
using the eQMS system.
- Execute internal and external audits, according to an approved
audit schedule; negotiate audit date, prepare and send agenda to
- Write audit reports and observations letters, issue audit
follow-up documents in a timely manner. Track open observations to
closure, as needed.
- Evaluate auditee's responses, communicate on compliance issues
and corrective actions identified from the audits.
- Determine and document decisions on supplier qualification
status, escalate critical findings to Sr. Management.
- Performs risks assessments for new vendors.
- Write, revise, and review procedures for the supplier
- Document audit observations and CAPAs in electronic
- Maintain and update the approved supplier list.
- Monitor CAPAs resulting from audits, as needed.
- Participate in regulatory audits, PAI readiness audits and
inspections as directed by QA Management.
- Review supplier change notifications and work with stakeholders
to determine impact to internal systems.
- Support Technical Quality Agreements management, write TQAs
using an internal template, and communicate with suppliers for
comment resolution and approval.
- Participate in cross functional projects, as needed.
- Provides back-up for the QA department, as needed.
- Up to 50% travel, domestic and international.
- BS / MS in a scientific or engineering discipline
- Minimum of 10 years of experience in pharmaceutical / biotech
industry within Quality Assurance
- Experience executing audits at following vendor types: API
Manufacturers (small molecules, preferred) Oral Dosage Form Drug
Product Manufacturers e.g. tableting, capsules, etc Clinical
Warehouses and Distribution Centers for clinical and commercial
drug products CROs Clinical Investigator Sites BIMOs (US and EU)
Packaging and Labeling operations PAIs
- Working knowledge of: Writing and negotiating Quality
Agreements Regulatory Compliance, Quality System Management and QA
principles and practices QMS electronic platforms FDA and EU cGMP
requirements as applicable to GxP areas Writing and revising GxP
- Use judgment in situations for which there are no
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects, in a fast-paced
- Self-motivated, organized, and strong technical skills
- Able to meet travel requirements
Keywords: Amylyx Pharmaceuticals, Cambridge , Head, Audit Management, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!