Sr. QMS Consultant

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 ConsultantJob SummaryThe 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 facilitiesQualificationsBachelor's degree in a related field; advanced degree preferred5+ years of experience in Quality Management System design and implementation in regulated industriesStrong knowledge of GMP principles and regulatory requirementsExperience with SOP and controlled document authoringExcellent communication and interpersonal skillsAbility to work independently and collaboratively with cross-functional teamsResponsibilitiesConduct interviews with company leaders to facilitate key strategic decisions related to quality system developmentDefine QMS structure, document hierarchy, and governance model for all operating companiesAuthor, customize, and standardize GMP documentation for all operating companiesSupport controlled rollout of QMS documents and implementation of quality processesProvide training on new SOPs and quality processes for laboratory, operations, and quality personnelEvaluate laboratory and production workflows, identifying opportunities for improvementDevelop optimized workflow and layout concepts to align operational improvements with GMP and quality objectivesDeliverablesComplete GMP QMS document suiteSite-specific SOPs and templatesTraining materials and completion reportsGMP Readiness Assessment and Action PlanMock Inspection Summary ReportLocation: 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