Manager/Sr Manager Quality SystemsSalary: $161k-$175k
Hybrid- Needham, MA office 3 days a weekPosition Summary: NOTE: Title flexibility (Manager/flexible) will be considered based on experience and impact.
- Location: Hybrid (3 days/week in Needham, MA; 2 days remote)
- Type: Individual contributor (may have future direct reports)
This is a highly visible, unique opportunity for a seasoned quality systems professional who thrives in fast-paced, resourceful environments. You'll report directly to the Sr. Director of Quality and serve as a strategic partner across departments, while leading Candel's Training and Documentation Control function, providing Quality Systems oversight of Deviations, CAPA, Change Control and other modules in ZenQMS and computer system validation. This role will also support Quality Operations activities like executed batch record or deviation review. You are a builder-of systems, of processes, of trust.
We don't believe in micromanagement here. We believe in hiring people who take ownership, follow through, and bring integrity to every detail. If you're ready to roll up your sleeves, drive change, and help bring a life-changing oncology therapy to market, read on.
This is not a role for the average. This is a role for someone ready to help launch a first-in-class therapy-and do it the right way.
What You'll Own - Training Program Management and Continuous Improvement
Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the organization by:- Executing on and enhancing the strategic objectives related to the training program including continuous process improvement.
- Generating and distributing periodic training-related metrics as well as expanded metrics and analysis in support of Quality Management Review.
- Acting as subject matter expert for the training program and providing inspection support for training related requests.
- Document/Record Management and Continuous Improvement
Oversee and execute the document management program by:- Executing on and enhancing the strategic objectives related to the document and record management program including continuous process improvement.
- Processing document creation and revision requests, editing documents and routing for review, approval, and archiving for all GxP document types including SOPs, batch records, protocols, reports, and approved external partner documents in ZenQMS.
- Leading and executing strategic improvements related to document management workflow within ZenQMS.
- Generating and distributing periodic document/record-releated metrics as well as expanded metrics and analysis in support of Quality Management Review.
- Acting as subject matter expert for the document and records program and providing inspection support for document/record related requests.
- GxP Quality Systems Leadership
Manage the end-to-end lifecycle of GxP quality systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.- Leading periodic status meetings for deviations and CAPA
- Facilitating periodic Change Review Board and Specification Review Board meetings
- Developing and publishing periodic quality systems metrics for Deviations, CAPA, and Change Control.
- Reviewing and approving Deviations, Product Complaints, CAPA, Change Control, Batch Records and Technical Reports
- Providing inspection support as subject matter expert for quality systems management and the eQMS platform ZenQMS as well as any other assisting role as assigned.
- Computer System Validation & Governance
Oversee all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. - Acting as the ZenQMS business process owner.
- Providing inspection support as subject matter expert for ZenQMS and the CSV program.
- Cross-functional Enablement
Support scientific teams (PD, analytical, R&D) by ensuring document and data integrity for BLA-enabling work. Bridge clinical and commercial quality expectations through practical systems thinking. - Quality Operations Support
Provide support for Quality Operations activities by providing quality review of various documents as requested based on experience/expertise.
What You Bring - Bachelor's degree in Life Sciences or a related technical field.
- 10+ years of experiencein biotech/pharma Quality Assurance, with direct ownership of GxP systems including document and training management and computer systems validation.
- Expertise witheQMS, EDMS, training systems, and other regulated platforms; familiarity with all GxP document types and training delivery mechanisms. Experience with ZenQMS preferred.
- Background inclinical-stage or hybrid clinical/commercial environments, with a hands-on approach to QA operations and system management.
- Strong understanding ofICH, FDA, and Part 11 requirements, and how they apply to cloud-based, outsourced, and evolving environments.
- Experience incross-functional quality enablement, supporting teams like PD, Analytical, IT, Clinical and Manufacturing in system compliance.
- Experience in supporting inspection and inspection readiness activities as a quality systems subject matter expert, computer system business process owner and CSV oversight.
- Critical thinker with the ability to navigate ambiguity, prioritize work, and maintain momentum without daily direction.
NOTE: All applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time. 
