BS/BA in a scientific or health-related discipline; advanced degrees or certifications preferred.
10+ years in biopharmaceutical or CRO Clinical R&D.
Experience in clinical quality risk management, quality assurance, or GCP auditing, preferably in a small biotech.
Familiarity with hematology/oncology trials is highly preferred.
Extensive knowledge of ICH GCP and global regulations, with practical application skills.
Experience with regulatory inspections and cross-functional global teams.
Proven project management skills and attention to detail.
Responsibilities
Perform GCP audits and develop audit schedules.
Act as a GCP subject matter expert, guiding complex compliance questions.
Review and report GCP Serious Breaches.
Deliver GCP training and develop training materials for teams and CROs.
Maintain knowledge of evolving global GCP regulations and assess impacts on operations.
Implement scalable quality processes to address regulatory gaps.
Manage regulatory inspection activities and facilitate mock inspections.
Benefits
Competitive base salary and annual performance-based bonuses.
Comprehensive medical, dental, and vision benefits starting on day one.
401(k) plan with company matching contributions.
Generous paid time off and company holidays, including year-end shutdown.
Paid parental leave and life/disability insurance.
Collaborative culture with passionate biotech professionals.
Mission-driven work focused on patient care.
Full Job Description
Job Summary:
The Director, Global Clinical Quality Assurance will provide hands-on execution for ADCTs GCP quality assurance and regulatory inspection readiness program. The role will assist with the implementation of quality strategies, development and maintenance of SOPs and quality processes, mock inspections, audit and inspection preparedness, and resolution of complex compliance issues, including serious breaches. The Director will serve as a GCP subject matter expert and quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, Drug Safety, CROs, and clinical sites. This role contributes to ADCTs mission by strengthening compliant, scalable quality systems and supporting reliable clinical trial conduct, patient protection, data integrity, and regulatory readiness. The Director is expected to operate independently in a fast-paced, matrixed biotechnology environment and maintain regular presence in the New Providence, NJ office based on business needs.
What You'll Do:
Job responsibilities may include, but are not limited to:
Perform GCP audits and contribute to GCP audit schedule development
Serve as a GCP subject matter expert for ADCT and provide guidance on complex GCP interpretation and compliance questions
Review, assess and report GCP Serious Breaches
Deliver GCP training to internal teams and CROs, develop training materials, and facilitate workshops
Maintain current knowledge of evolving global GCP regulations and assess potential impacts on ADCT operations
Implement scalable quality processes where gaps exist, applying pragmatic, compliant solutions that meet regulatory requirements and support business objectives
Develop and maintain the Clinical Quality Manual with direct responsibility for content
Provide hands-on management of regulatory inspection activities, including developing inspection plans, preparing teams and documentation, facilitating mock inspections with external vendors, and serving as a quality liaison during actual inspections
Coordinate inspection readiness across clinical sites, CROs, and internal functions, and drive assigned corrective actions when gaps are identified
Facilitate internal mock audits and inspections, including developing scenarios, conducting interviews, and providing actionable feedback
Serve as a quality partner for Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and Drug Safety
Quality Issue Management & CAPA: Manage the classification of Quality Issues, support critical issue escalation, and oversee assigned CAPA effectiveness activities.
Regulatory Strategy and Compliance: Collaborate with Regulatory Affairs and Clinical Operations to align quality assurance activities with clinical development plans. Update and adapt quality processes to reflect changes in regulatory standards and best practices
Maintain regular presence in the New Providence, NJ office, as needed
Other duties, as assigned
Requirements
Who You Are:
BS/BA degree, clinical/science degree or certification (e.g. RN, NP, MSN, PharmD, PhD, MD, AS, RTT, MT, etc.), in a scientific or health related discipline.
Minimum of 10 years of experience in the biopharmaceutical industry or at a Contract Research Organization in Clinical R&D.
Experience working directly in a clinical quality risk management, quality assurance or GCP auditing role. Experience in these roles at a small biotechnology company is also preferred.
Experience in hematology/oncology trials is highly preferred.
Extensive knowledge of ICH GCP and relevant global regulations and guidelines with the ability to apply the principles.
Experience interacting with inspectors and cross-functional, global teams is required.
Experience in working in an outsourced model for clinical trials is preferred.
Experience developing processes, computer systems and training materials to support an effective quality management system.
Strong project management skills and demonstrated ability to look at the big picture when making decisions and accounting for what may be in the best interest of ADCT.
Attention to detail with an ability to perform critical review of various types of documents.
Ability to independently solve problems and facilitate resolution of issues.
Demonstrated ability to work as a team player with multi-disciplinary project teams.
Demonstrated ability to work independently but also in a team environment, exercise sound judgment, and adapt to changing work environment(s).
Excellent verbal, written, and interpersonal communication skills.
Ability to travel globally up to ~20%.
What We Offer:
Competitive biotech base salary, annual target bonus (eligibility based on company performance) or quarterly IC (field sales roles) and new hire stock options - so you share in the value you help create
Medical, Dental and Vision benefits which start on the 1st day of employment
401(k) with company match
Paid time off and company holidays including a company wide shut down at the end of the year
Paid Parental Leave, Life and Disability Insurance, Tax advantaged health savings and spending accounts
A hands-on, collaborative culture with other passionate biotech professionals
