Regulatory & Quality (Life Sciences)·Confirmed live in the last 24 hours·
Full-timeNeedham, MA, USA$161k - $175k /yr
About the Job
Requirements
A bachelor's degree in Life Sciences or a related technical field.
At least 10 years of experience in biotech or pharmaceutical Quality Assurance, with direct ownership of GxP systems including document and training management and computer systems validation.
Expertise with electronic quality management systems, electronic document management systems, training systems, and other regulated platforms; familiarity with all GxP document types and training delivery mechanisms.
A background in clinical-stage or hybrid clinical/commercial environments, with a hands-on approach to quality assurance operations and system management.
A strong understanding of ICH, FDA, and 21 CFR Part 11 requirements and their application to cloud-based, outsourced, and evolving environments.
Experience in cross-functional quality enablement, supporting teams such as product development, 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 oversight lead.
Authorization to work in the United States without requiring sponsorship.
Responsibilities
Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the organization.
Execute and enhance strategic objectives for the training program, including continuous process improvement.
Generate and distribute periodic training-related metrics and expanded metrics and analysis for Quality Management Review.
Serve as the training program subject matter expert and provide inspection support for training-related requests.
Oversee and execute the document management program, including continuous improvement of its strategic objectives.
Process document creation and revision requests, edit documents, and route them for review, approval, and archiving for all GxP document types, including SOPs, batch records, protocols, reports, and approved external partner documents in ZenQMS.
Lead and execute strategic improvements to document management workflows within ZenQMS.
Generate and distribute periodic document and record metrics and expanded metrics and analysis for Quality Management Review.
Serve as the document and records program subject matter expert and provide inspection support for related requests.
Manage the end-to-end lifecycle of GxP quality systems across Quality Assurance, Clinical Operations, CMC, and Research, ensuring compliance with 21 CFR Part 11 and industry standards.
Lead periodic status meetings for deviations and CAPA.
Facilitate periodic Change Review Board and Specification Review Board meetings.
Develop and publish periodic quality systems metrics for Deviations, CAPA, and Change Control.
Review and approve Deviations, Product Complaints, CAPA, Change Control, Batch Records, and Technical Reports.
Provide inspection support as a subject matter expert for quality systems management and ZenQMS, and perform other assigned supporting duties.
Oversee computer system validation activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations.
Act as the ZenQMS business process owner.
Provide inspection support as a subject matter expert for ZenQMS and the computer system validation program.
Support scientific teams in product development, analytical, and research and development by ensuring document and data integrity for BLA-enabling work.
Bridge clinical and commercial quality expectations through practical systems thinking.
Support Quality Operations by providing quality review of documents as requested based on experience and expertise.
Desired Qualifications
Experience with ZenQMS is preferred.
Manager/Sr Manager Quality Systems Salary: $161k-$175k Hybrid- Needham, MA office 3 days a week
Why Work With Us? Candel is a clinical-stage biopharmaceutical company developing innovative multimodal viral immunotherapies designed to harness the power of the immune system against cancer. With positive Phase 3 results from our lead program and BLA readiness underway, Candel is reaching an important inflection point—one that creates the opportunity to translate scientific innovation into meaningful impact for patients, while the company continues to advance the next generation of programs across solid tumors.
This is an exciting time for Candel as we evolve from a focused clinical-stage biotechnology company toward an integrated biopharmaceutical organization. Our people are at the heart of that journey! We believe breakthrough science is powered by people who challenge convention, bring different perspectives, collaborate across disciplines, and focus on shared outcomes. Candel’s culture is grounded in trust, flexibility, accountability, creativity, and a shared commitment to one goal: improving the lives of patients and their families. Learn more: www.candeltx.com
Position 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 experience in biotech/pharma Quality Assurance, with direct ownership of GxP systems including document and training management and computer systems validation.
Expertise with eQMS, EDMS, training systems, and other regulated platforms; familiarity with all GxP document types and training delivery mechanisms. Experience with ZenQMS preferred.
Background in clinical-stage or hybrid clinical/commercial environments, with a hands-on approach to QA operations and system management.
Strong understanding of ICH, FDA, and Part 11 requirements, and how they apply to cloud-based, outsourced, and evolving environments.
Experience in cross-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.