Senior Manager, GMP and QMS Quality Operations

Jobgether

7d • $150,000 - $175,000 • Remote

About The Position

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.

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.

Responsibilities

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level