Description
Qualifications:• Extensive experience in quality assurance and regulatory compliance in the pharmaceutical and medical device sectors.
• Expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation.
• Proven ability to act as a mediator and communicator between technical teams and regulatory bodies.
• Strong networking skills with a proven track record of applying industry best practices.
• Excellent mentorship and coaching abilities.
• Strong experience with GMP, GLP, GxP, and other relevant regulatory standards.
• Strong experience with Lean and Agile Software Development Lifecycle Procedure
Additional Requirements:
• The consultant should have a robust network within the pharmaceutical industry to facilitate the exchange of best practices and innovative compliance strategies.
• Flexibility to work in projects executed in different time zones USA (Boston), Europe (Vienna, Austria), and Japan
• Experience with Jira.