Resilience · 4 hours ago
Senior Specialist, Quality Assurance
USA - PA - East Norriton
Full-time
Onsite
Mid, Senior Level
$75K/yr - $120K/yr
5+ years expResilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Senior Quality Assurance Specialist will organize and execute aspects of cGMP implementation at the East Norriton manufacturing facility, ensuring compliance with quality systems in support of gene therapy and cell therapy manufacturing.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
No H1B
Responsibilities
Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program
Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations
Review and approve deviations, change controls, CAPAs and other applicable quality records
Review and approve laboratory investigations
Conduct quality oversight, review and approve of method qualifications and validations
Author, review, and approve technical documents including but not limited to SOPs, various quality reports and assessments
Review and approve Test Methods and SOPs associated with Quality Control, as needed
Approval of drug product Certificate of Analysis (CoA/CoT) required for the manufacturing process
Participate in the oversight and changes to the LIMS environment
Quality oversight of the GMP Material Enrollment Program, inclusive of supplier quality tasks for the East Norriton site
Release of GMP materials utilized in the manufacturing process
Manages client communications, escalations, and documentation, as needed
Supports audits/inspections for the East Norriton site, as needed
Mentor, coach and train Quality Associates in the QA Operations Team and other departments
Completes qualified program requirements necessary to train other employees
Support Quality Assurance team members, as needed
Qualification
Required
Relevant life sciences quality experience within quality and/or quality related functions
Demonstrated track record supporting quality operations and/or systems
Demonstrated quality experience and the ability to collaborate with and effectively influence others
Preferred
B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field)
Five years of specific experience with cell therapy and/or viral vector assays / methods strongly preferred
Experience with electronic laboratory information management systems
Familiarity with electronic quality systems/software applications
Familiarity with manufacturing execution systems
Working knowledge of GLP/GCP and GxP Regulatory requirements
Experience in preparation and participation in regulatory authority plant/site inspections
Benefits
Annual cash bonus program
401(k) plan with a generous company match
Healthcare (including medical, dental and vision)
Family building benefits
Life and disability insurance
Flexible time off
Paid holidays
Other paid leaves of absence
Tuition reimbursement
Support for caregiving needs
Company
Resilience
Resilience is a biomanufacturing company that provides access to complex medicines and protects biopharmaceutical supply chains.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$3.36BKey Investors
Oak Hill AdvisorsAdministration for Strategic Preparedness and ResponseMubadala
2025-10-29Debt Financing· $825M
2024-10-03Grant· $17.5M
2023-03-24Debt Financing· $410M
Leadership Team
William Marth
President & Chief Executive Officer
Susan Billings
Chief Commercial Officer (CCO)
Recent News
Help Net Security
2025-11-11
2025-11-05
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