Senior Manager, GMP and QMS Quality Operations job opportunity at Jobgether.

Jobgether Senior Manager, GMP and QMS Quality Operations

Experience: 10 Years

Pattern: Remote

Country:

Apply Now

Salary:

Status:

Others

Copy Link Report

Bachelor's (B.Sc.)

United States ..........United States Of America

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, GMP and QMS Quality Operations in United States.This role offers a strategic and hands-on opportunity to lead Quality Operations within a regulated environment, ensuring compliance, operational excellence, and continuous improvement across GMP and QMS processes. You will oversee quality workflows, training programs, vendor management, and process optimization initiatives while collaborating with cross-functional teams to drive measurable impact. This position allows you to influence organizational quality culture, support product lifecycle management from clinical development through commercialization, and ensure regulatory readiness. It combines operational oversight with leadership in training, project execution, and process improvement in a dynamic, mission-driven environment.\nAccountabilities:Provide strategic and operational support across GMP Quality and Quality Management Systems (QMS), including internal batch record review, batch disposition, and manufacturing operations.Serve as a QA partner on change controls, CAPAs, deviations, OOS, and non-conformances, facilitating root cause analysis and ensuring timely closure and effectiveness.Lead and oversee vendor management, including planning and scheduling CSV validation activities with external partners.Drive continuous improvement initiatives by identifying inefficiencies, risks, and trends, and implementing corrective actions across Quality workflows.Manage training programs and compliance oversight, ensuring KPIs are tracked, gaps are addressed, and learning initiatives are implemented effectively.Participate in cross-functional projects, audit management, SOP/documentation updates, and quality enhancement initiatives to strengthen operational excellence.Represent Quality Operations on project teams, with external partners, and across departments to promote alignment and adherence to regulatory standards.Requirements:Bachelor’s degree in life sciences or related discipline.7–10+ years of experience in QA, QMS, QC, or Manufacturing within FDA-regulated industries, preferably biologic therapeutics.Comprehensive understanding of GMP and QMS requirements across the full product lifecycle from clinical development to commercialization.Direct experience interacting with regulatory authorities (e.g., BLA, MAA submissions and/or inspections).Proven ability to lead improvement initiatives using Root Cause Analysis, data analytics, LEAN, DMAIC, or Six Sigma methodologies.Demonstrated leadership skills in a matrixed organization, including influencing, negotiating, and building alignment across diverse teams.Strong proficiency in Veeva Quality Suite and related quality management systems.Excellent verbal and written communication, critical thinking, and problem-solving skills.Benefits:Competitive base salary of $150K – $175K USD, with bonus and equity offerings.Comprehensive medical, dental, vision, disability, and life insurance coverage.401(k) matching with immediate vesting, ESPP, and tuition reimbursement.Generous PTO, holidays, and parental leave to support work-life balance.Wellness program with monthly stipend and professional development opportunities.Remote and flexible work arrangements within the US.Supportive, inclusive, and patient-focused culture with opportunities for career growth.\nWhy Apply Through Jobgether?We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1

Other Ai Matches

Remote

Head of Interfaces (Remote from Sweden) Applicants are expected to have a solid experience in handling Security & IT – IT related tasks

Remote

Enterprise Account Executive Applicants are expected to have a solid experience in handling Sales – Account Executive related tasks

Remote

Legal Counsel (Remote from Ireland) Applicants are expected to have a solid experience in handling Legal related tasks

Remote

Senior Customer Success Manager (Remote from Bulgaria) Applicants are expected to have a solid experience in handling Customer Success – Support related tasks

Remote

Creative Director (Mobile Ads & UA) Applicants are expected to have a solid experience in handling Marketing – Marketing related tasks

Remote

Product Operations Coordinator Applicants are expected to have a solid experience in handling Research & Development – Product related tasks

Remote

Senior Product Manager (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Remote Data Engineer Applicants are expected to have a solid experience in handling General – General related tasks

Remote

SEO Specialist (Remote from Israel) Applicants are expected to have a solid experience in handling Marketing – Marketing related tasks

Remote

Technical Customer Success Manager (Creator Economy) Applicants are expected to have a solid experience in handling Customer Success – Support related tasks

Remote

SEO Specialist (Remote from Denmark) Applicants are expected to have a solid experience in handling Marketing – Marketing related tasks

Remote

Remote DevOps Engineer Position Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Senior Creative Producer (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

SEO Specialist (Remote from Luxembourg) Applicants are expected to have a solid experience in handling Marketing – Marketing related tasks

Remote

Senior Software Engineer, Wikimedia Enterprise Applicants are expected to have a solid experience in handling Security & IT – IT related tasks

Remote

Research Operations Coordinator - REMOTE Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Senior Content Engagement Manager (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Remote Lead Electrical BIM Project Manager Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Manager Operations Execution - REMOTE Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Data Entry Professional (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Principal Data Scientist (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Lead Data Engineer (Remote) Applicants are expected to have a solid experience in handling General – General related tasks

Remote

Performance Marketer Applicants are expected to have a solid experience in handling Marketing – Marketing related tasks

Senior Manager, GMP and QMS Quality Operations job opportunity at Jobgether.

Saved Jobs

No Job Saved

Other Ai Matches