Senior Quality Specialist/ Quality Manager

Who we are looking for:

Vor Bio is seeking a Senior Quality Specialist/ Quality Manager who can work cross functionally to provide quality oversight and support to various groups for the purpose of maintaining validated state of the facility, equipment and/or systems as well as quality compliance support.

Key areas of responsibility:

• Provide quality oversight of facility/utility and equipment for qualification activities.
• Provide quality oversight of validation program which includes but is not limited to Commissioning, Qualification, Validation, Analytical Instruments Validation, Method Validation, and Process Validation.
• Quality support for IT, Computer/Enterprise Systems Validation activities
• Review of lifecycle documents such as URS, DQ, SAT, FAT, design documents, qualification protocols (IQ, OQ & PPQ) generated for the qualification and validation of equipment and systems.
• Review equipment and automation qualification and validation protocols.
• Carries out duties in compliance with all local, state, and federal laws and guidelines including the FDA, EU.
• Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements vital to maintain a validated status. Supports process, and method validation efforts.
• Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
• Support review and approval of generation of quality assurance policies and procedures.
• Support interpret and implement quality assurance standards.
• Quality expert responsible for maintaining change control system. Provide QAV support and assessments on change controls. Review for execution approval of change controls per change control SOP and client agreement.
• Provides quality support for change control, deviations and CAPA’s.
• Provides support for internal/external audit program
• Provides quality compliance support to MFG, QC, Facilities, PD/PAD groups.
• Supports 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.

Qualifications:

• 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.