Director, Global Clinical Quality Assurance
ADC Therapeutics
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.
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.
What You'll Do
- Perform GCP audits and contribute to GCP audit schedule development
- Serve as a GCP subject matter expert 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
- 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
- Manage the classification of Quality Issues, support critical issue escalation, and oversee assigned CAPA effectiveness activities
- 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
Requirements
- 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
- 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 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
- 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%
- Experience in these roles at a small biotechnology company is also preferred
- Experience in hematology/oncology trials is highly preferred
- Experience in working in an outsourced model for clinical trials is preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Company Holidays
- Paid Parental Leave
- Life Insurance
- Disability Insurance
- Health Savings Accounts
- Spending Accounts
- Stock Options
- Annual Bonus
Company overview
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs), specializing in oncology therapeutics. Founded in 2011 and headquartered in Lausanne, Switzerland with operations in New Jersey, the company focuses on developing highly potent and targeted ADCs for the treatment of hematological cancers and solid tumors. Their flagship product, ZYNLONTA® (loncastuximab tesirine-lpyl), is a CD19-directed ADC that received accelerated FDA approval and conditional European Commission approval for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The company leverages specialized capabilities spanning clinical development, manufacturing, and commercialization, with a proven track record that includes an approved and marketed product. ADC Therapeutics maintains a global team of over 300 employees and operates with a flat organizational structure that encourages collaboration and innovation. Beyond ZYNLONTA, the company is advancing IND-enabling activities for a next-generation PSMA-targeting ADC and exploring combination therapies and earlier lines of treatment. Their mission centers on transforming cancer treatment paradigms through targeted ADC technology and bringing novel therapeutic options to patients worldwide.