Associate Director/Director of Quality

About Outpace Bio

Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing unrivaled AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming key barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. By creating and integrating modular, plug-and-play technology assets, we are developing cell therapies with unprecedented efficacy, transforming how engineered T cells interact with cancer and the immune system to deliver life-changing outcomes. Our multidisciplinary team of scientists, engineers, coders, and cell therapy developers works at the cutting edge of computational protein design, synthetic biology, and immunology. Together, we are reimagining how cells function to unlock novel therapeutic possibilities.Located in Seattle’s vibrant biotech hub overlooking scenic South Lake Union, Outpace Bio is led by pioneers in computational protein design and engineered cell therapies. Our culture is built on a foundation of respect and inclusion, which are fundamental to how we collaborate to revolutionize cell therapy through groundbreaking innovation rooted in rigorous science.

Our Commitment to Diversity

At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to cultivating an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Our Momentum

In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors. This funding accelerates our pipeline of programmed T cell therapies, including our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpace’s proprietary OUTSMART™, OUTLAST™, OUTSPACER™, and OUTSAFE™ technologies. OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers. The Series B investment also supports the expansion of our pipeline, enabling us to develop additional transformative therapies leveraging our innovative plug-and-play technology platform.

To enable this vision, we are seeking an Associate Director/Director of Quality. The Associate Director/Director of Quality will lead all aspects of our quality assurance and quality control programs, serving as a key leader within Outpace. This critical role will collaborate closely with internal teams and external contract manufacturing partners to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and industry standards specifically related to T-cell therapies. The successful candidate will provide strategic leadership, ensuring the integrity and quality of Outpace’s cell therapy products throughout clinical development. This role requires proactive engagement, strategic decision-making capabilities, and hands-on experience to identify and mitigate quality risks. The Associate Director/Director of Quality will also be instrumental in shaping quality culture and practices across the organization, ensuring readiness for regulatory inspections and driving continuous improvement initiatives to maintain the highest standards of product quality and patient safety. The position reports to the Head of Technical Operations and Quality, and is located in Seattle, WA.

• Quality Management System (QMS):
• Develop, implement, manage, and continuously improve the company's Quality Management System (QMS).
• Establish and maintain comprehensive quality documentation, including policies, procedures, work instructions, and records.

• Contract Manufacturing Organization (CMO) Oversight:
• Lead and manage quality oversight activities with CMOs, including audits, inspections, document reviews, and vendor qualification.
• Review completed batch records and certify that batches are manufactured, packaged and labeled in compliance with GMP and suitable for release.
• Conduct thorough investigations into manufacturing deviations, oversee root cause analysis, and drive effective corrective and preventive actions (CAPA).

• Regulatory Compliance:
• Ensure cGMP compliance in the manufacturing, testing, and release of T-cell therapy products for clinical trials.
• Prepare for and coordinate responses to regulatory agency audits and inspections, ensuring inspection readiness at all times.
• Lead and support the preparation of quality sections for regulatory submissions, providing strategic input to ensure approval readiness.

• Cross-functional Collaboration:
• Collaborate effectively with Regulatory Affairs, Clinical Operations, R&D, and other internal stakeholders to align on quality-related strategies and regulatory compliance.
• Provide strategic guidance on quality and compliance considerations for product development and clinical trials.
• Support process and analytical technology transfer activities between internal and external manufacturing operations

• Risk Management and Continuous Improvement:
• Perform and oversee quality risk assessments, proactively identifying potential issues and developing mitigation strategies.
• Drive continuous improvement initiatives to enhance operational efficiency and product quality standards.

• Validation and Qualification Oversight:
• Provide quality oversight for the qualification and validation of analytical methods, equipment, and manufacturing processes.
• Ensure that validation activities and documentation meets regulatory expectations and supports clinical development milestones.

• Leadership and Team Development:
• Mentor, manage, and develop quality personnel, fostering a culture of quality excellence, accountability, and continuous improvement.
• Facilitate ongoing training programs to enhance quality knowledge and practices across the organization.

• BS degree in Biology, Chemistry, Life Sciences, or a related discipline; advanced degree preferred.
• Minimum of 10 years of progressive experience in Quality Assurance and/or Quality Control within the biotechnology or pharmaceutical industry.
• Significant experience in T-cell therapy or related biologics manufacturing is essential.
• Proven track record of successful interactions and management of Contract Manufacturing Organizations.
• Extensive knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Experience with Phase 1/2 clinical stage T-cell therapy development and associated regulatory expectations.
• Demonstrated experience in building and implementing internal Quality Management Systems from the ground up.
• Strong background in conducting quality audits, inspections, and regulatory submissions.
• Excellent problem-solving abilities, with experience in risk assessment, root cause analysis, and CAPA processes.
• Proven leadership and team-building skills, capable of mentoring and developing high-performing quality teams.
• Strong interpersonal, organizational, and communication skills, with the ability to influence stakeholders at all levels.
• Demonstrated capability to manage and prioritize multiple projects effectively and efficiently.

The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting. Actual base salary will be based on a variety of factors including skills, experience, and other related factors permitted by law.

Working at Outpace offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world.

Outpace Bio Total Rewards

Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment and a performance bonus. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and fifteen paid holidays plus a winter shutdown. Outpace also offers a generous paid parental leave policy to all regular full-time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

Salary : $157,000 - $225,000