Manager, Clinical Quality

Arcellx; Redwood City (CA); On-site; USD 135,000 - 155,000; Full time

Job summary

An established industry player is seeking a Clinical Quality Manager to ensure regulatory compliance for clinical trials. This pivotal role involves leading quality oversight for innovative cell therapy studies, developing audit strategies, and ensuring adherence to Good Clinical Practice (GCP) standards. You will collaborate with talented professionals in a supportive environment, making a significant impact on the lives of patients. With a strong focus on values such as collaboration and originality, this organization offers a dynamic workplace where your contributions are valued. Join the mission to advance cell therapy and help destroy cancer.

Benefits

100% medical, dental, and vision coverage

Unlimited vacation

3-day weekends every month

Fully-paid parental leave for up to 6 months

Tuition reimbursement

401k employer contribution

Annual bonus based on company goals

Equity (RSU) grant

Relocation assistance

Qualifications

• 8+ years of experience in GCP within pharmaceuticals or biologics.
• Experience in clinical quality systems in regulated environments.

Responsibilities

• Lead clinical quality oversight for phase I, II, and III studies.
• Develop audit plans and conduct internal and external audits.
• Provide compliance guidance to clinical teams.

Skills

GCP Compliance

Clinical Quality Systems

Risk Assessment

Communication Skills

Presentation Skills

Education

Bachelor’s Degree

Job description

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.
• 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

As our Manager, Clinical Quality, your mission is to support all GCP quality oversight as it relates to Arcellx’s phase I, II and III clinical studies. Partnering with clinical and medical affairs, you’ll ensure our quality system provides sufficient oversight and is compliant with applicable regulations for our GCP programs and activities. In this role, your work will directly impact our ability to run successful clinical trials and get our potentially life-saving therapy to patients.

The “Fine Print” – What You’ll Do

• Act as a Clinical Quality lead by supporting study team compliance with national and international regulatory standards and guidance for cell therapy products.
• Develop audit plans and audit strategy for ongoing clinical trials.
• Perform initial and ongoing audits of clinical vendors.
• Coordinate, plan, and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented.
• Participate in the development of clinical standard operating procedures, work instructions, forms, and templates.
• Develop and conduct training for staff (GCP, Inspection Readiness training, etc.).
• Support preparation for and execution of regulatory inspections.
• Provide quality and regulatory compliance guidance to clinical colleagues.

Skills and Experience We Look For

• Bachelor’s degree and 8+ years’ experience working within GCP in a pharmaceutical or biologics environment. Experience in Clinical Quality in a related industry (i.e. medical device or diagnostics) will be considered. More experienced candidates may be considered at the senior level.
• Experience implementing and integrating clinical quality systems in CBER regulated biotechnology companies.
• Knowledge of applicable GCP regulations and industry guidance.
• Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.
• Strong communication and presentation skills with good relationship-building.
• Ability to travel up to 20% of time.

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 estimated base salary range for this position for manager-level candidates is $135,000 - $155,000. The senior manager-level range is $155,000 to $180,000 per year. Where a candidate falls within that range is determined by factors such as years of experience and education. 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.

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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