Senior QMS Consultant - GMP Readiness & Process Improvement

Pinnaql; Louisville (KY); Remote; USD 80,000 - 110,000; Full time

Job summary

A trusted consulting partner for life sciences is seeking a Sr. QMS Consultant primarily for remote work with occasional site travel. This role involves designing Quality Management System documents, aiding in quality system development, and ensuring GMP readiness. The ideal candidate will possess strong expertise in QMS design, regulatory requirements, and be effective in cross-functional collaboration. An advanced degree and relevant experience are preferred. Join a supportive team and make a meaningful impact in healthcare.

Qualifications

• 5+ years of experience in Quality Management System design and implementation in regulated industries.
• Strong knowledge of GMP principles and regulatory requirements.
• Ability to work independently and collaboratively with cross-functional teams.

Responsibilities

• Conduct interviews with company leaders to facilitate key strategic decisions related to quality system development.
• Define QMS structure, document hierarchy, and governance model for all operating companies.
• Author, customize, and standardize GMP documentation for all operating companies.
• Support controlled rollout of QMS documents and implementation of quality processes.

Skills

Quality Management System design

GMP principles

SOP authoring

Communication skills

Collaborative work

Education

Bachelor's degree in a related field

Advanced degree preferred

Job description

A trusted consulting partner for life sciences is seeking a Sr. QMS Consultant primarily for remote work with occasional site travel. This role involves designing Quality Management System documents, aiding in quality system development, and ensuring GMP readiness. The ideal candidate will possess strong expertise in QMS design, regulatory requirements, and be effective in cross-functional collaboration. An advanced degree and relevant experience are preferred. Join a supportive team and make a meaningful impact in healthcare.