Manager, Quality Management Systems

Role Summary

The Manager, Quality Management System is responsible for the global management and support of the Quality Management Systems which include Quality Events, CAPA, Continuous Improvement, Effectiveness and Change Control. The primary role of this position will be to manage boards, ensure business process oversight of the eQMS system, including guidance to users, reports, metrics, procedures, and drive on time closure of records. In addition, identify and support enhancements and/or releases for electronic QMS systems, conduct training, and update relevant procedures. Additional activities included inspection readiness, support for internal audits and inspections as required. The Manager will also support Document Management and Training systems as required. The role will assist in management reviews, inspection readiness activities and backroom for inspection. The individual will be a team player able to influence and work cross functional with GXP functions in a small company environment.

Responsibilities

• Develop and report metrics for Change Control, Deviations, CAPA, Continuous Improvement and Effectiveness checks. Coordinate the metrics with other key stakeholders (training, document management, supplier quality etc.) to ensure QMS monitoring.
• Manage and support enhancements or releases of the electronic QMS systems (Veeva). This includes system requirement setting, execution of UAT, revising procedures, training material creation/updates and roll out.
• Provide status reports, relevant indicators to department management and follow-up and/or escalation for those QMS systems under the scope of responsibility.
• Partner with key functional areas to provide guidance on QMS and ensure consistent application of system practices and regulations.
• Support various Management Review forums. Includes QMS Board Meetings (e.g. Deviations, CAPA, CRB, etc.)
• Support Internal, External Audits and Health Authority Inspections as SME for QMS. Support Back-room activities for Health Authority inspections with document request activities or other needed roles.
• Lead or support Quality Management system, Quality projects and continuous improvement initiatives.
• Perform other duties as assigned.

Qualifications

• Education: Bachelor’s degree in life sciences (Biology, Chemistry, Microbiology, Biochemistry etc.) or related engineering field.
• Experience: 8+ years of relevant experience in the biotech/pharmaceutical industry specifically in Quality Management Systems or related areas.
• Licenses or Certifications: Related certifications (ASQ, SQA, ISO) are preferred but not required.

Skills

• Working knowledge of QMS system and regulations for Biopharmaceuticals, Pharmaceuticals or Medical Devices.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency in the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Additional Requirements

• Travel: 5-10% (as needed)
• Safety: Comply with all pertinent safety policies, rules and regulations.