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Head, Audit Management

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: February 19, 2021

Job Description:

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 auditees.
  • 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 management program.
  • Document audit observations and CAPAs in electronic system.
  • 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 documents
        • Use judgment in situations for which there are no precedents
        • Outstanding communication skills (verbal and written)
        • Ability to manage multiple projects, in a fast-paced environment
        • Self-motivated, organized, and strong technical skills
        • Able to meet travel requirements

Keywords: Amylyx Pharmaceuticals, Cambridge , Head, Audit Management, Executive , Cambridge, Massachusetts

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