MV01-030526 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 DeliverablesComplete 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.