Senior Quality System Manager Consultant
This is a key role in our organization that requires a Senior Quality System Manager Consultant to join our teams and play a crucial part in our development.
Responsibilities:
* Verify the company's compliance with ISO/cGMP quality system requirements, including 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.
* Ensure the oversight of compliance for Change Controls, CA/PA, and investigations, OOS, and deviations.
* Perform external audits of suppliers/vendors/off-site facilities.
* Serve 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 multiple projects simultaneously.
* May lead and direct the work of others. Review and approve validation documents.
* Review and Master Batch Records (MBR) and supporting documents.
* Release 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 skills, including 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, organizational skills, record-keeping skills, and the ability to handle multiple projects.
We are looking for someone who values individual performance and wants to share their skills within a cohesive team where experiences are freely shared.
We are open to all talents and committed to diversity and inclusion.
Seniority Level:
Associate
Employment Type:
Full-time
Job Function:
Quality Assurance
Industries:
Business Consulting and Services and Biotechnology Research