Manager, Clinical Quality Redwood City, CA

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

Job summary

Join a pioneering biotechnology firm as a Clinical Quality Manager, where you will play a crucial role in ensuring the integrity and compliance of clinical trials. This position offers the chance to directly impact the development of innovative cell therapies aimed at combating cancer and other serious diseases. Embrace a collaborative and inclusive environment that values your unique contributions while working alongside a team of passionate innovators. With a strong commitment to employee well-being, enjoy a competitive salary, generous benefits including unlimited vacation, and a culture that encourages professional growth. This is your opportunity to make a meaningful difference in the lives of patients.

Benefits

100% Medical Coverage

Unlimited Vacation

3-Day Weekend Every Month

Fully-Paid Parental Leave

Tuition Reimbursement

401k Employer Contribution

Annual Bonus

Equity (RSU) Grant

Relocation Assistance

Qualifications

• 8+ years of experience in GCP within pharma or biologics.
• Strong knowledge of GCP regulations and industry guidance.

Responsibilities

• Lead compliance with GCP standards for clinical studies.
• Develop and conduct audits of clinical vendors and internal systems.

Skills

GCP Compliance

Clinical Quality Oversight

Risk Assessment

Communication Skills

Presentation Skills

Education

Bachelor's Degree

Tools

Clinical Quality Systems

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.

#LI-Onsite

Apply for this job

* indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Arcellx is an onsite company that believes in the power of in-person connection and collaboration. Our beautifully designed office provides space for quiet, focused work, while fostering opportunities for meaningful engagement with colleagues. Are you willing and able to work onsite in our Redwood City, CA office? *

Are you authorized to work for any employer in the United States? *

Will you now or in the future require visa sponsorship? *

What makes you an ideal candidate for this role and a great fit for our company? Briefly tell us about your unique combination of work experience and values. *