Director of IT Quality Operations at ADC Therapeutics in New Providence, NJ

Description

Company Profile

Founded in 2011, ADC Therapeutics is a small, fast growing company focusing on the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors.

The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers with significant unmet need. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. There are operations in Lausanne Switzerland (Head office and Clinical), London UK (R&D), New Jersey US (Clinical and Commercial) and San Francisco US (CMC manufacturing). ADC Therapeutics encourages a flexible work environment, so their employees can work from wherever. For more information, please visit the company website www.adctherapeutics.com.

Position Overview

The Director of IT Quality Operations is responsible for managing the appropriate design/development, deployment and maintenance of validated computer systems to ensure data integrity. Additionally, this role will provide project management support for validation projects and is responsible for change management for validated computer systems, as well as developing and maintaining IT policies, procedures and work instructions that support maintaining the validated state.

This position will report to the Head of Business Information Services.

Job Responsibilities

• Ensure that external service providers are adequately assessed and establishes necessary agreements, procedures and governance to enable maintaining a validated state and ensuring data integrity.
• Provide project management services for validation projects, in collaboration with the computer system validation lead and business owner
• Implement and maintain change management processes for validated computer systems; maintain the validated state
• Author, review and maintain IT/IS Policies, SOPs and Work Instructions
• Assess external service providers and establish appropriate agreements, governance charters (including KPIs) and monitor performance
• Standing member of data governance committee and change review board
• Identify opportunities for continuous improvement
• Serve as IT/IS representative in internal and external audits, including regulatory inspections
• Contribute to the overall IT/IS department strategy

Requirements

• Bachelor’s degree or equivalent within a related field of study
• 8+ years of related experience in Pharmaceutical IT or equivalent field
• Direct experience acting as a project manager and/or managing changes related to software/systems such as Veeva, ARGUS Safety, Medidata RAVE, Analytical Software (SAS, JMP, R) and drug product distribution/inventory (ERP, Trackwise)
• Familiarity with regulations and guidelines related to clinical, manufacturing and laboratory systems, and specifically GAMP, 21 CFR Part 11/Annex 11, HIPPA, GDPR, SOX and CCPR
• Excellent communication and writing skills
• Experience with regulatory inspections preferred