This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
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.
#J-18808-Ljbffr
Worksite address
louisville, KY, 40201, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.