Senior Manager, QA Operations

TScan is looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be based in our cGMP Manufacturing site in Waltham, MA, and will directly support cGMP Clinical Cell Therapy manufacturing and commercialization activities.

The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control, Supply Chain Material Receipts and Inventory Management and Facilities, with a focus on supporting real-time triaging and documentation review. The ideal candidate will have experience working in a GMP Manufacturing facility, experience with cell and gene therapy, and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

This position may include 20-30% of weekend work (either Saturday or Sunday) to support Clinical Manufacturing.

Responsibilities:

Responsibilities include but are not limited to:

* Manages, coaches, and develops the growing team of QA Specialists

* Provide QA oversight of production, QC, and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), and on-the-floor oversight. Provides the production, QC, MSAT, and supply chain teams with QA/Compliance guidance and decisions

* Initiate and own CAPAs, Deviations, change controls, review and approval of deviations / non-conformances, and lead the strategic discussion for investigations with respect to operations or batch release related matters.

* Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chain.

* Support training program for QA operations specialists which include training curricula, raw material dispositions, batch issuance, and batch record review and release training curriculum as well as operational quality systems and compliance.

* Drive continuous quality improvement program for manufacturing operations and partner with the production, QC, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.

* Collaborate effectively with QA systems team and cross-functional teams to deliver results.

* Lead internal audit for the QA operations team and ensure inspection readiness.

* Act as a Deputy to Quality Assurance Operations Head.

* Actively drive high-quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.

Requirements:

* BS degree in a relevant scientific discipline required, at a minimum.

* 10+ years of relevant biotech/pharma industry experience, with at least 3 years combined relevant experience in Aseptic GMP manufacturing Operations and Quality Assurance covering GMP manufacturing operations.

* Experience with supervising/managing direct reports

* Experience working with Phase 1 through commercial products and building compliance.

* Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections by major Health Authorities (e.g., US FDA).

* In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations.

* Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity.

* Strong data tracking, trending, and analysis skills.

* Strong communications skills, a team player who can lead, mentor, and inspire others.

* Gene or cell therapy product experience preferred.

* Demonstrated success in delivery of key milestones against tight timelines.

* Ability to prioritize, manage time well, multitask, troubleshoot.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities.

To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position…