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Lead, R&D and Quality Systems Operations

Company: Amylyx Pharmaceuticals
Location: Cambridge
Posted on: November 22, 2022

Job Description:

With recent approvals in the US and Canada Amylyx Pharmaceuticals is launching a new drug for the treatment of adults with ALS.
If you are looking for a place where your work can have a deeper impact than you ever imagined and where you can be true to yourself - Amylyx is the place for you!
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.
The Opportunity
This role will be responsible for all aspects of IT related to the support of R&D and Quality Organizations. The functional teams you will directly interact with include Regulatory, Pharmacovigilance (Safety), Biometrics, Clinical; and Quality, encompassing Quality Systems, Audit, GMP & GCP teams. The responsibilities of this role include leading the application validation and support of Veeva Vault Development Cloud modules related to each function; aligning with appropriate business partners to ensure Amylyx has a stable, robust, and scalable set of applications to support growing business needs.
This position will encompass many activities including evaluating new functionality while maintaining the integrity of integrated applications; partnering with other members of the IT team, delivering on the business goals, refine existing solutions, and prioritize the day-to-day needs for each of the existing solutions. This is a critical role to support the key functions of Amylyx's R&D and Quality organizations.
The Role

  • Identification, implementation and support of systems utilized by R&D and Quality.
  • Elicit, document, and execute on systems strategy and business requirements for each function.
  • Support change management and governance activities by partnering with key business users to ensure new items are tested and implemented to meet the business needs.
  • Lead Computer System Validation activities and resources as required. Oversee test script creation, user testing and user documentation for GxP classified systems.
  • Introduce best practice and process improvement ideas where appropriate.
  • Occasionally manage projects using project management best practices.
  • Manage external partners regarding applications and enhancements in line with the overall company objectives and solution capabilities.
  • Coordinate issue resolution with internal and external support providers.
  • Work with other IT team members to maintain roadmap for the integration of Vault platforms with Amylyx (e.g., Commercial CRM, MDM, data warehouse and analytical platforms).
  • Develop ad hoc reports up request, using the tools available within the applications based on input from the business.
  • Lead small-group training sessions as needed.
  • Continuing education focused on new applications and/or functionality to meet organizational growth as additional needs arise.
  • Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
    The Requirements
    • Bachelor's degree in computer science or related field strongly preferred.
    • Minimum of 8 years of IT experience with progressively increasing technical and support responsibilities.
    • Experience in pharmaceutical/biotech industry GxP regulated functions, including Implementing/supporting applications following regulated Computer System Validation protocols.
    • Experience administering Veeva Vault (or equivalent) solutions and/or platform Certifications preferred.
    • Experience in working with Veeva Vault Quality & Development Cloud products is a plus.
    • Experience in interpreting the applicability of local and federal laws/regulations) to company operations.
    • Demonstrated ability to manage several complex deliverables at the same time
      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 date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As 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.
      To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
      To return to our website please click here .
      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.

Keywords: Amylyx Pharmaceuticals, Cambridge , Lead, R&D and Quality Systems Operations, Other , Cambridge, Massachusetts

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