Senior Director, Global Clinical Quality Assurance
Senior Director, Global Clinical Quality Assurance
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1 Vacancy
Job Description
Position: Senior Director Global Clinical Quality Assurance
Location: Hybrid/Remote (New Providence NJ)
Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics you will join a group of talented people who share this mission.
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma ZYNLONTA (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA ADC Therapeutics has a PSMA-targeting ADC in ongoing development.
We are a team of approximately 200 patient-focused purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If youre interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues operating in a flexible work environment come join us on our journey! To learn more about ADC Therapeutics our values and our exceptional culture please visit us at and LinkedIn.
Position Overview:
As the Senior Director of Global Clinical Quality Assurance this position will lead our global clinical quality assurance strategy and execution of the strategy to ensure compliance with Good Clinical Practice (GCP) and regulatory standards. This role requires substantial experience with US and international audits and inspections a deep understanding of GCP and the ability to maintain the highest quality standards in clinical research.
This position reports to the VP Global Quality Assurance. This is a hybrid role with the expectation of regular in-office presence in our New Providence NJ office anticipated to be at least a few days each month or as business needs require.
What Youll Do
Job Responsibilities:
Global Quality Oversight: Develop and implement global quality assurance policies and procedures that comply with GCP and regulatory requirements across different regions. Develop and own the Clinical Quality Manual provide Quality oversight for GCP vendors and CROs and collect analyze and report KQIs for Executive Management Review. Accountable for the overall effectiveness of the overall GCP Quality System
Audit Management: Lead and manage comprehensive audit programs of service providers clinical sites and electronic systems including both routine and for-cause audits to ensure adherence to GCP and regulatory compliance.
Inspection Management: Oversee preparation and response strategies for both US and ex-US regulatory inspections. Accountable for all GCP Regulatory inspection management and readiness activities including but not limited to preparation and execution of mock inspections as well as inspection management.
Cross-Functional Collaboration: Proactively cultivate and sustain strong trust-based relationships with key internal stakeholders across Clinical Science Clinical Operations Development GMP Quality Assurance Biostatistics Pharmacovigilance Clinical Supply Chain Regulatory Affairs Legal and Executive Leadership to support a unified approach to clinical quality. Navigate matrixed cross-functional dynamics to identify and resolve identified compliance risks driving alignment and implementing timely pragmatic and globally compliant solutions.
Quality Issue Management & CAPA: Accountable for classification of Quality Issues critical issue escalation and CAPA Effectiveness.
Regulatory Strategy and Compliance: Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans. Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices.
Stakeholder Engagement: Serve as the primary clinical quality assurance liaison with regulatory authorities partners and internal stakeholders. Ensure transparent communication and collaboration on GCP quality-related matters.
PV Quality: Establish and manage Pharmacovigilance Quality Assurance processes
Other duties as assigned
Who You Are
Qualifications:
Bachelors degree in Life Sciences Pharmacy or related field is required. An advanced degree is preferred.
At least 15 years of experience in clinical quality assurance within a global organization including extensive GCP-focused work and managing international audits and inspections is required. Experience in a small biotechnology company is also preferred.
Certification in Quality Assurance such as CQA or RQAP-GCP preferred.
Experience handling Clinical Quality Assurance for a Phase 3 study including preparation for and successful participation in an FDA regulatory inspection for the study. Additional experience with international regulatory agency inspections preferred.
Experience with PV Quality preferred.
Experience in hematology/oncology trials 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 strongly preferred.
Experience in working with an outsourced model for clinical trials is required.
Hands-on leadership style with a strong bias for action; actively engages in the execution of clinical quality initiatives rather than solely directing from a high levelserves as a key contributor in driving projects forward alongside the team.
Strong project management skills with the ability to manage complex clinical quality initiatives from end-to-end ensuring timelines deliverables and stakeholder alignment.
Experience working in dynamic environments where collaboration with internal teams and external consultants is critical to success.
Skilled at navigating ambiguity and conflict fostering alignment and delivering pragmatic compliant solutions in high-stakes regulated settings.
Excellent communication skills capable of effectively presenting and discussing complex issues to influence outcomes.
Attention to detail with an ability to perform critical review of various types of documents.
Demonstrated ability to work as a team player with multi-disciplinary project teams.
Ability to travel 15% as needed to office locations and for business meetings.
ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive professional and respectful work environment where employees are empowered for success.
Required Experience:
Exec
Employment Type
Full Time
