Full-Time

Senior Quality Specialist/ Quality Manager

Vor Bio

Vor Bio

51-200 employees

Engineering cells for targeted blood cancer therapies

Biotechnology

Senior, Expert

Cambridge, MA, USA

Required Skills
Data Analysis
Requirements
  • Bachelor's degree in sciences/engineering
  • Minimum 8 years of biotech/pharmaceutical industry experience or 12 years of biotech/pharmaceutical industry experience in lieu of degree
Responsibilities
  • Provide quality oversight of facility/utility and equipment for qualification activities.
  • Provide quality oversight of validation program including Commissioning, Qualification, Validation, Analytical Instruments Validation, Method Validation, and Process Validation.
  • Quality support for IT, Computer/Enterprise Systems Validation activities.
  • Review lifecycle documents such as URS, DQ, SAT, FAT, qualification protocols (IQ, OQ & PPQ).
  • Review equipment and automation qualification and validation protocols.
  • Carry out duties in compliance with local, state, and federal laws and guidelines including the FDA, EU.
  • Provide technical support on change controls for process equipment, utilities, and automation systems. Support process and method validation efforts.
  • Provide quality oversight of engineering and validation studies, data analysis, and compilation of data and results into summary and final reports.
  • Review and approve generation of quality assurance policies and procedures. Interpret and implement quality assurance standards.
  • Maintain the change control system. Provide QAV support and assessments on change controls. Review and approve execution of change controls per change control SOP and client agreement.
  • Support change control, deviations, CAPA's. Support internal/external audit program. Provide quality compliance support to MFG, QC, Facilities, PD/PAD groups.
  • Support continuous improvement of Vor Quality Systems. Quality support for CMMS work orders, NCRs, Change Requests.
  • Support deviation investigations, OOS investigations, root-cause analysis, and CAPA generation. Assure ongoing compliance with quality and industry regulatory requirements.
  • Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data.

Company Stage

N/A

Total Funding

$267.8M

Headquarters

Cambridge, Massachusetts

Founded

2015

Growth & Insights
Headcount

6 month growth

4%

1 year growth

20%

2 year growth

33%
INACTIVE