Senior Manager Quality Systems (Remote)

100% remote job
Senior Manager Quality Systems | ADC Therapeutics | Canada
100% remote job
Senior Manager Quality Systems | ADC Therapeutics | Canada
Job Type
Full-time
Description
Senior Manager- Quality Systems
Description
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 a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and has also received European Commission approval. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We are a team of over 300 patient-focused, purpose-driven employees who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn.
What You’ll Do
Position Overview
As the Quality Systems Senior Manager, you will be responsible for managing and assessing quality event records, chairing review board meetings, reporting metrics, and driving continuous improvements to ensure our Quality System is effective and efficient. The incumbent will ensure that ADCT’s deviation, change control, and CAPA records accurately and appropriately document events and are in an inspection-ready state. This role will routinely work cross-functionally within ADCT and with external parties to drive accurate root cause determination and identification of effective CAPAs to mitigate recurrence across our operations.
This role reports to the Director, Quality Systems, based in San Mateo, CA with a significant portion of work being performed remotely.
Who You Are
Job Responsibilities

• Chair Deviation, Quality, and Change Review Boards as needed, including agenda preparation, meeting facilitation, and formal issuance of minutes
• Communicate effectively with teams, drive continuous process improvement, and provide quality and GMP compliance guidance.
• Create and revise Standard Operating Procedures (SOPs) associated with shared Quality Systems that drive consistent and compliant execution in clinical and commercial operations
• Other responsibilities as directed by manager
• Support internal audit, inspection readiness, and inspection management activities
• Identify and report on Quality metrics to monitor the status and heath of ADCT’s Quality System and the operations it supports
• Manage ADCT Quality Event records, including Deviations, Change Controls, and CAPAs, to industry requirements
• Support vendor deviations and investigations to ensure ADCT’s requirements are met

Requirements
Requirements

• Bachelor’s degree in chemistry, biology, or related scientific field; advanced degree desirable but not required
• Evidence of strong strategic thinking, planning, and organizational skills
• Ability to work independently and manage priorities in a remote setting while making sound quality/compliance-based decisions
• Excellent communication skills for both written and verbal presentations as well as meeting facilitation and documentation
• Excellent project and data management skills and a keen attention to details

Experience

• Experience with writing, reviewing, and defending deviation and investigation reports
• Experience in execution of internal audits and management of routine GxP inspections.
• 6+ year’s industry experience in Quality Unit and/or Compliance roles.
• Recent experience in GMP Quality Assurance, Quality Control, and/or Manufacturing
• Experience with commercial products

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.
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Tagged as: remote, remote job, virtual, Virtual Job, virtual position, Work at Home, work from home
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Tagged as: remote, remote job, virtual, Virtual Job, virtual position, Work at Home, work from home