Manager/Sr Manager Quality Systems

Candel Therapeutics•Needham, MA

6d•$161,000 - $175,000•Hybrid

About The Position

Candel is hiring a Quality Systems professional at the Manager or Senior Manager level. This highly visible individual-contributor role reports to the Senior Director of Quality and partners across departments. The position leads the Training and Documentation Control functions and provides Quality Systems oversight for deviations, CAPA, change control, other ZenQMS modules, and computer system validation. It also supports Quality Operations activities, including review of executed batch records and deviations. The role may have direct reports in the future. The position manages and continuously improves GxP training and document/record management programs, including program metrics, analysis, knowledge management, and inspection support. It oversees GxP quality systems across QA, Clinical Operations, CMC, and Research; supports review boards and quality-system reviews; and serves as the ZenQMS business process owner. It also oversees computer system validation activities and helps scientific teams maintain document and data integrity for BLA-enabling work. The role is hybrid, based in Needham, Massachusetts, with three days per week in the office and two days remote. Applicants must be authorized to work in the United States without sponsorship.

Requirements

Bachelor's degree in Life Sciences or a related technical field.
At least 10 years of experience in biotech or pharmaceutical Quality Assurance.
Direct ownership of GxP systems, including document management, training management, and computer system validation.
Expertise with eQMS, EDMS, training systems, and other regulated platforms.
Familiarity with GxP document types and training delivery mechanisms.
Experience in clinical-stage or hybrid clinical/commercial environments, with hands-on involvement in QA operations and system management.
Strong understanding of ICH, FDA, and 21 CFR Part 11 requirements and their application to cloud-based, outsourced, and evolving environments.
Experience supporting cross-functional teams such as PD, Analytical, IT, Clinical, and Manufacturing in system compliance.
Experience supporting inspections and inspection readiness as a quality-systems subject matter expert, computer-system business process owner, and CSV overseer.
Ability to think critically, navigate ambiguity, prioritize work, and maintain momentum without daily direction.
Authorization to work in the United States without employer sponsorship.

Nice To Haves

Experience with ZenQMS.

Responsibilities

Lead and continuously improve the GxP training program, including its strategic objectives and processes.
Deliver GxP systems training and support knowledge management across the organization.
Generate and distribute periodic training metrics and analyses for Quality Management Review.
Serve as a training-program subject matter expert and provide inspection support for training-related requests.
Oversee and execute the document and record management program, including continuous improvement.
Process document creation and revision requests; edit, route, approve, and archive GxP documents in ZenQMS, including SOPs, batch records, protocols, reports, and approved external-partner documents.
Lead improvements to document-management workflows in ZenQMS.
Generate and distribute periodic document and record metrics and analyses for Quality Management Review.
Serve as a document- and records-program subject matter expert and provide inspection support.
Manage the lifecycle of GxP quality systems across QA, Clinical Operations, CMC, and Research, ensuring compliance with 21 CFR Part 11 and applicable industry standards.
Lead periodic deviation and CAPA status meetings.
Facilitate periodic Change Review Board and Specification Review Board meetings.
Develop and publish periodic metrics for deviations, CAPA, and change control.
Review and approve deviations, product complaints, CAPA, change controls, batch records, and technical reports.
Provide inspection support as a subject matter expert for quality systems and ZenQMS, and perform other assigned support roles.
Oversee computer system validation activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations.
Act as the ZenQMS business process owner and provide inspection support for ZenQMS and the CSV program.
Support scientific teams, including PD, analytical, and R&D, by ensuring document and data integrity for BLA-enabling work.
Bridge clinical and commercial quality expectations through practical quality-systems approaches.
Support Quality Operations by reviewing documents as requested based on experience and expertise.