Amylyx Looking for Lead, Quality Audit Management at Remote Full Time

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Are you looking for a place where your work can have a deeper impact than you ever imagined—and where you can be true to yourself?

At amylyx, we`re bringing together talented people like you who are committed to solving for humanity`s most devastating diseases, including amyotrophic lateral sclerosis (als), alzheimer`s disease, and others—all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.

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.

We provide a competitive employee benefits package including stock options and rsus; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.

Position summary

This newly created position will be a key member of the quality leadership teamThe lead, quality audit management is accountable for supporting the risk-based vendor management program for amylyx gxp quality, and for providing support in presenting the program during regulatory inspections, if requiredThe individual is responsible for planning, conducting, and closing gxp vendor audits to assess amylyx`s vendors and clinical site`s level of compliance with gxp regulations, guidelines, internal procedures, and industry best-practicesIn this role you will act as the secondary contact point for all audit related communication with vendorsYou will be responsible for supporting the maintenance of the approved vendor list and sustainment of the quality technical agreements program.

Responsibilities

Support development of yearly audit plan per internal procedures and manage using the eqms system.
Execute and close out internal and external audits per an approved audit schedule, and write audit related documents (agendas, reports, etc.).

Document audit observations, evaluate auditee`s responses and capas in electronic system and monitor until closure.
Determine and document decisions on supplier qualification status, escalate critical findings to senior management.
Perform risks assessments for new vendors and maintain and update the approved vendor list.
Write, revise, and review procedures for the supplier management program and generate kpis for audit management.
Participate in regulatory audits, pai readiness audits, bimo readiness visits and inspections as directed by qa management.
Support technical quality agreements management, write tqas using an internal template, and communicate with suppliers for comment resolution and approvalMonitor periodic qta review dates and follows up on revisions.
Participate in cross functional projects and provide back-up to for the qa department, as needed.
Up to 50% travel, domestic and international.

Requirements

Bs / ms in a scientific or engineering discipline
Minimum of 5 years of experience in pharmaceutical / biotech industry within quality assurance, executing audits at following vendor types:

Api manufacturers (small molecules, preferred)
Oral dosage form drug product manufacturers e.gTableting, capsules, etc.
Clinical warehouses and distribution centers for clinical and, preferable also for commercial drug products
Cros
Clinical investigator sites
Bimos (us and eu)
Packaging and labeling operations
Pais
Contract testing labs

Working knowledge of:

Writing and negotiating quality agreements
Regulatory compliance, quality system management and quality assurance principles and practices
Qms electronic platforms
Fda and eu cgmp requirements as applicable to gxp areas

Write and revise 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

Covid-19 vaccination policy: candidates should be aware that amylyx`s current covid-19 policy requires that all newly hired us-based employees be fully vaccinated against covid-19 prior to their employment start dateAmylyx may amend its covid-19 policy going forward, including, but not limited to, requiring booster vaccinationsAmylyx is an equal opportunity employerAs required pursuant to federal, state, and local law, amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Watch this inspirational video of how our co-founders worked with patheon and thermo fisher in the early days of starting amylyx.

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Amylyx is proud to be an equal employment opportunity employerWe 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 characteristicsAccommodations are available for candidates who require them in our selection processIf you need an accommodation, please let your amylyx talent acquisition contact know.

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Posted 30+ days ago