What are the responsibilities and job description for the Head, Quality Management Systems position at Amylyx Pharmaceuticals Inc?
Amylyx was started in 2013 by two Brown University students who had an ambitious goal : to improve the lives of people with neurodegenerative diseases by addressing the root cause.
Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). At Amylyx, we're bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable. Our mission would not be possible without each individual perspective within our team. It's a culture that uses unconventional thinking for unsolved problems.
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.
THE OPPORTUNITY
Amylyx is looking for a Head of Quality Management Systems who oversees the Quality Systems that are responsible for developing, maintaining, and executing Quality Management Systems (QMS) and processes to ensure GxP compliance. Oversees the GXP systems by developing and supporting the Documentation Management System (DMS), Learning Management System (LMS) and Quality Management System (QMS) for Deviations, CAPAs, change control and complaints including process improvement implementations that meet business and regulatory requirements. The Quality Management Systems team is responsible for complaints, APQR, Recalls and Quality oversight of Computer System Validation.
This role oversees Quality Management Systems and manages their team for internal implementation as well as integration with contracted partners. With the expansion of the company, this role will support the implementation and operation of development and commercial quality systems.
THE RESPONSIBILITIES
- Manages a team and directly performs the following :
- Manage implementation, validation, and management for deviations, CAPA, Complaints and Change Control. Monitor the overall health of the QMS, generate KPIs and drive continuous improvement of the QMS.
- Responsible for Quality oversight of Data Integrity and Computer System Validation activities.
- Approve and review non-compliance events, for example, deviations, OOS, investigations, etc. that occur during production and testing, investigate and support remediation.
- Oversee operations of the Document Control and Records Management and the Training and Personnel Qualification processes.
- Develop training strategies and materials that support GXP activities, including continuous improvement initiatives.
- Write, review and / or approve SOPs for QA clinical and commercial systems e.g. software usage, complaints, annual product review.
- Provide system oversight and ensure system compliance and usage to regulatory and corporate requirements as they related to document control and records management.
- Manage Annual Product Quality Reviews.
- Support cross functional teams in processing document requests, document approval, and document archival.
- Support implementation and qualification of software for Quality Management Systems
- Review and approve SOPs for quality.
- Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives.
- Represents Amylyx QA. Creates Agendas and manage resources to drive Amylyx needs and timelines.
- Promote a Culture of Quality through collaboration
REQUIRED QUALIFICATIONS
WORK LOCATION AND CONDITIONS
traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
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Amylyx is proud to be an Equal Employment Opportunity employer. We 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 characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
