Associate Director, Global Quality (R&D)
Pay Range: $90,000.00 – $115,000.00 per year
Travel may be required.
We are partnered with a biotechnology organization that believes in the potential of engineered cells as medicine, and is composed of a team that wants to lead with the desire to work on novel ideas. Our client is in the clinic with their lead CAR T programs in autoimmune disease and oncology and developing cell and gene therapies in autoimmune disease, oncology, and type 1 diabetes.
About the role: The Associate Director, Global Quality R&D plays a pivotal role in shaping, executing, and sustaining a global quality compliance framework across R&D and bringing collaboration with other GxP functions. Acting as both a strategist and tactical quality representative, this role ensures alignment with international regulatory standards while driving inspection readiness, vendor oversight, proactive risk governance, and continuous training improvement.
This individual will lead complex compliance projects, provide oversight of outsourced audits, and partner with business and QA stakeholders to embed quality into operational practices. With a focus on R&D, the position supports laboratory, clinical, and development teams in meeting high internal quality expectations and regulatory requirements, strengthening training programs, and advancing robust GxP system builds and management that withstand the scrutiny of health authorities across multiple regions.
Beyond oversight, the Associate Director is expected to be a change agent who will champion process improvement, embedding Lean practices, and influencing a culture of quality accountability. The role requires exceptional project management and relationship‑building skills, the ability to navigate ambiguity, and the foresight to identify risks before they materialize.
This position contributes to inspection readiness strategies, policy and SOP governance, and the development of enterprise‑wide best practices. The role balances tactical execution with strategic insight, ensuring that R&D and cross‑functional teams are prepared not only to meet compliance obligations but to excel in quality delivery that accelerates innovation and safeguards study subjects worldwide.
What you’ll do:
Regulatory Compliance & Inspection Readiness
- Ensure compliance and inspection readiness for all study records, meeting 21 CFR Part 58, 21 CFR Part 11 (where applicable), and FDA requirements for IND-enabling non-clinical studies, as well as ICH Good Clinical Practice (GCP) standards for clinical development activities.
- Maintain and execute a wide variety of complex compliance-related projects across global R&D, with an emphasis on phase-appropriate quality approaches that scale with development milestones.
- Lead or advise during vendor, investigator, and regulatory inspections (GLP, GCP, GVP and other GxPs), including preparation, support, and follow-up activities.
- Provide oversight for outsourced audits and support directed or for-cause audits as needed.
- Participate in the development and execution of a global Inspection Readiness (IR) function , ensuring both nonclinical and clinical teams are consistently inspection-ready.
Quality Systems & SOP Governance
- Partner as a member of the QMS team to drive completion of GxP SOPs, providing input for R&D specific needs, SOPs, policies, and governance.
- Participate in writing, updating, and reviewing SOPs, Work Instructions, and policies with phase-appropriate controls to balance compliance and flexibility in early- vs. late-stage programs.
- Collaborate with QMS and IT in QMS maintenance, expansion , applying expertise in data integrity and regulatory systems; manage daily operations of the portions of the QMS that are paper based, the eQMS , and other systems for R&D departments.
- Support workflow owners for QMS technology platforms and contribute to global system governance.
Risk Management & Continuous Improvement
- Support proactive risk identification, resolution, and governance across R&D programs in partnership with other QA and business stakeholders as required.
- Analyze risk, propose corrective/preventive actions, and recommend innovative approaches, with phase-appropriate escalation and mitigation strategies.
- Review and analyze key performance indicators (KPIs) and compliance trends across R&D, using data to inform quality priorities.
- Champion continuous improvement initiatives , embedding Lean practices across laboratory, clinical, and development functions.
- Promote a culture of quality accountability, continuous learning, and operational excellence across the organization.
Study Oversight & Archiving
- Oversee clinical quality documentation, ensuring study conduct meets ICH GCP standards and that oversight is phase-appropriate from first-in-human to pivotal trials.
- Oversee retention of raw data, documentation, protocols, reports, and study samples in line with GLP/GCP regulations and approved protocols.
Cross-Functional Collaboration & Training
- Establish strong communication with Study Directors, Study Monitors, Principal Investigators, QA, and other key stakeholders across R&D.
- Provide compliance support to cross-functional teams and QA functions, spanning laboratory and clinical operations.
- Lead training improvements to ensure staff understand GLP, GCP, and broader GxP expectations, tailored with phase-appropriate requirements to match development stage needs.
- Assist study teams in resolving compliance errors, tracking document timelines, and ensuring accurate filing in electronic systems.
- In partnership with procurement and legal, drive execution and life-cycle oversight of legal contracts (CDAs/NDAs, MSAs, SOWs, POs), ensuring reliable execution of outsourced nonclinical and clinical activities.
- Liaise with study teams, Legal, and Finance to track, maintain, and manage contracts with vendors supporting both preclinical and clinical programs.
- Support the expansion and build of the vendor quality management expectations for R&D quality leveraging cross-collaboration with other GxP Quality members.
What we’re looking for:
- Bachelor’s degree in a scientific discipline with 7 years of relevant experience, or an equivalent combination of education and work experience, preferably within the pharmaceutical or biotechnology industry.
- Strong understanding of quality structure and design principles, with experience managing Quality Systems across GxPs, with emphasis on R&D quality.
- Detail-oriented with the ability to multi-task, prioritize, and work effectively in cross-functional team environments.
- Clear and effective communicator, both verbally and in writing.
- Excellent interpersonal, organizational, and problem-solving skills with the ability to manage multiple projects at varying phases and ensure timelines are met.
- Demonstrated expertise with Veeva Vault and in the deployment/validation of GxP systems.
- Proficiency with MS Office (Word, Excel, PowerPoint) and Smartsheet.
- Skilled in addressing problems of diverse scope and exercising sound judgment in decision-making.
- Proven ability to manage fast-paced projects with flexibility and adaptability to shifting priorities.
- Collaborative mindset and strong team player with the ability to build positive working relationships.
- Demonstrates curiosity, scientific rigor, and a commitment to continuous learning.
- Comfortable engaging in crucial conversations, including giving and receiving feedback constructively.
- Ability to work effectively in both remote and onsite environments; up to 15% travel may be required.
What will separate you from the crowd:
- What will set you apart in this role is your ability to balance strategic foresight with tactical execution across the full R&D spectrum, experience with Cell and Gene Therapies, experience in areas of nonclinical through late-stage clinical. You won’t just ensure compliance; you will build and evolve phase-appropriate quality systems that scale with development milestones and withstand global regulatory scrutiny. Your deep understanding of Quality System builds and standards, combined with hands‑on expertise in eQMS management, vendor oversight, and inspection readiness, will allow you to anticipate risks before they surface and implement proactive, innovative solutions.
- You will distinguish yourself as a change agent and collaborator who is able to bridge R&D and GxP functions, strengthen training programs, and influence teams to embed quality into everyday operations. By combining your curiosity, scientific rigor, and Lean process improvement mindset with strong project management and relationship-building skills, you’ll not only deliver compliance but also drive a culture of accountability and continuous learning. Ultimately, you will help ensure that quality becomes a competitive advantage for the organization, accelerating innovation and safeguarding patients worldwide.