Director, GCP Quality Operations

Atlas Venture; United States; Remote; USD 200,000 - 215,000; Full time

Job summary

A leading biotech firm seeks a Director for GCP Quality Operations to provide expertise in quality assurance and compliance. This role ensures patient safety and data integrity, involves global collaboration, and offers a competitive salary. Candidates should have significant experience in GLP/GCP/GVP quality assurance and strong problem-solving skills.

Qualifications

• 10+ years in GLP/GCP/GVP quality assurance or risk management is required.
• Experience in pharmacovigilance QA is strongly preferred.
• Ability to work independently in a matrix environment.

Responsibilities

• Lead investigations, root cause analysis, and CAPA processes.
• Ensure quality in vendor assessments, audits, and compliance activities.
• Support inspection readiness and participate in audits.

Skills

Communication

Problem-Solving

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

About Day One Biopharmaceuticals

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine.

Job Description

At Day One, we focus on advancing first- or best-in-class medicines for childhood and adult diseases. We were founded to address the lack of new therapies resulting from the traditional drug development model, which has left children with cancer and their families waiting too long for new treatments. Our goal is to accelerate targeted treatments so patients of all ages can look forward to a better future from ‘day one’.

POSITION SUMMARY:

The Director, GCP Quality Operations provides expertise in GCP regulations, pharmacovigilance, global regulations, and industry best practices. The role ensures patient safety and data integrity, supporting quality assurance to achieve compliance, inspection readiness, and continuous improvement.

This is a global role involving partnerships across various teams. The position may be fully remote with occasional travel for meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Report to the Senior Director, GXP Quality Assurance
• Participate in the Quality Council
• Partner with Quality teams to ensure standards and harmonization
• Collaborate with local and global staff, external contacts, and regulatory authorities as needed
• Ensure quality in vendor assessments, audits, and compliance activities

Primary Responsibilities

• Represent GCP/GLP/GVP quality interests in vendor and system assessments
• Guide teams on training, quality, and compliance issues
• Lead investigations, root cause analysis, and CAPA processes
• Develop and review process documents and SOPs
• Monitor quality metrics and trends, proposing improvements
• Develop quality agreements with vendors and support risk management
• Support inspection readiness and participate in audits

Quality Management

• Provide quality support for clinical research activities
• Assist in risk-based audit planning and continuous improvement initiatives
• Ensure compliance with policies and regulations
• Promote risk management and inspection preparedness

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred
• 10+ years in GLP/GCP/GVP quality assurance or risk management
• Excellent communication and problem-solving skills
• Experience in pharmacovigilance QA is strongly preferred
• Ability to work independently in a matrix environment
• Willingness to travel up to 25%

We value authenticity and transparency in our candidates. Our hiring process involves multiple interviews and background checks to ensure alignment with our values and skills.

Compensation and Benefits

Salary range: $200,000 - $215,000, based on experience and other factors.

We are committed to diversity and equal opportunity employment. Employment is conditioned on COVID-19 vaccination proof. We do not sponsor work visas at this time.