Senior Quality System Manager Consultant

Senior Quality System Manager Consultant

As part of our development, we are recruiting a Senior Quality System Manager Consultant to join our teams.

Responsibilities:

• Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to GMP Part 1 and 2 or the EU Guidelines to GMP Medicinal Products for Human and Veterinary Use.
• Provide immediate support to operations and quality control staff to address compliance related concerns.
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Perform external audits of suppliers/vendors/off-site facilities.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
• Prioritize and manage a variety of projects simultaneously.
• May need to lead and direct the work of others. Review and approve validation documents.
• Review and Master Batch Records (MBR) and supporting documents.
• Perform review/release of batch records, as needed.

Your Profile:

• 5-10 Years Experience
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
• The ability to interface and communicate directly with clients is required.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.

Do you want to join the consulting world in a human-sized company that values the individual and performance?

To share your skills within a cohesive team where experiences are freely shared?

CONSULTYS is open to all talents and is committed to diversity and inclusion.

Seniority Level:

Associate

Employment Type:

Full-time

Job Function:

Quality Assurance

Industries:

Business Consulting and Services and Biotechnology Research