MV01-030526 Sr. QMS Consultant

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

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr. QMS Consultant

Job Summary

The Sr. QMS Consultant will be responsible for designing and authoring Quality Management System (QMS) documents, assisting with QMS architecture and governance, authoring SOPs and controlled documents, and supporting QMS implementation and GMP readiness for lab and manufacturing facilities

Qualifications

• Bachelor's degree in a related field; advanced degree preferred
• 5+ years of experience in Quality Management System design and implementation in regulated industries
• Strong knowledge of GMP principles and regulatory requirements
• Experience with SOP and controlled document authoring
• Excellent communication and interpersonal skills
• 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
• Provide training on new SOPs and quality processes for laboratory, operations, and quality personnel
• Evaluate laboratory and production workflows, identifying opportunities for improvement
• Develop optimized workflow and layout concepts to align operational improvements with GMP and quality objectives

Deliverables

• Complete GMP QMS document suite
• Site-specific SOPs and templates
• Training materials and completion reports
• GMP Readiness Assessment and Action Plan
• Mock Inspection Summary Report
• Location: There will be occasional travel to the site, but primarily remote.

This role requires an individual with a strong background in QMS design, authoring, and implementation, who can drive continuous improvement and operational excellence within the organization.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.