What is the role of a Senior Manager, GMP and QMS Quality Operations at Jobgether?

The Senior Manager, GMP and QMS Quality Operations position at Jobgether is a Full-time or part-time position opportunity in the Executive/Management field.

Where is this Senior Manager, GMP and QMS Quality Operations job located?

United States, Other / Non-US, United States

What type of employment is offered for this Senior Manager, GMP and QMS Quality Operations role?

Full-time or part-time position

What is the expected salary for this Senior Manager, GMP and QMS Quality Operations job?

Compensation will be discussed during the hiring process.

How can I apply for the Senior Manager, GMP and QMS Quality Operations position at Jobgether?

You can apply directly through the application link provided.

Senior Manager, GMP and QMS Quality Operations at Jobgether

Senior Manager, GMP and QMS Quality Operations

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.

Accountabilities:

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:

Bachelors degree in life sciences or related discipline.
710+ 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.

Why 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.

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Senior Manager, GMP and QMS Quality Operations at Jobgether – United States

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