Director, IT Compliance
Job Description
Who We Are
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Gaithersburg, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
- Character: Committed to always doing what’s right.
- Audacity: Willing to challenge convention and share candid feedback with others.
- Determination: Curious and self-motivated. Always looking to improve and learn. Â
- Collaboration: "No job is too small" mentality. Humble and willing to help others.
- Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
How You’ll Make a Difference
In this role, you’ll own all aspects of our IT compliance, system/software change and release programs. Your work on governance, risk, and compliance management of our IT operations, and strategic planning for software releases, changes, ITGC and validation activities across teams will ensure our company is able to deliver on our mission of bringing a transformative cell therapy to market and potentially saving patient lives.
The “Fine Print” – What You’ll Do
- Implement and maintain IT Compliance and Risk Assessment model.
- Develop and enhance IT Change Management Framework.
- Drive process improvement initiatives within the IT organization.
- Ensure continued compliance with regulatory (SOX, Privacy, HIPPA, 21 CRF Part 11, etc) requirements and internal control standards, serving as central point of data gathering.
- Lead development and maintenance of IT's Computer Validation System (CVS) SOP.
- Collaborate with Corporate Compliance on compliance roadmaps and IT strategy.
- Establish influential relationships to assess and mitigate business and IT risks.
- Develop measurable IT audit plans and policies, SOPs, and IT Controls.
- Work with 3rd party vendors to ensure effective and auditable controls are in place.
- Evaluate training needs and deliver content to support the control environment and foster a compliance & risk aware culture.
Skills and Experience We Look For
Our ideal candidate holds a bachelor’s degree in information technology, CS, business, finance, engineering, or a relevant field, and has 10+ years’ work experience in IT positions with a progression in role sophistication and an emphasis on IT operation, delivery, or development services.
They must be able to demonstrate they have the technical knowledge to be successful in the role, such as experience working in an FDA regulated environment (GxP), experience with Software Development Life Cycle (SDLC) or relevant framework, and an understanding of processes and financial controls listed above. We’ll also look for an excellent communicator with strong project management, problem solving, and analytical skills.
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The base salary range for this position is $200,000 - $240,000 per year. Where a candidate falls within that range is determined by factors such as years of experience and location. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.Â
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com.
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Date Posted
10/11/2023
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5
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