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! 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 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Senior Manager, GMP and QMS Quality Operations
Location
United States
Posted
18 days ago
Salary
Not specified
No structured requirement data.
Job Description
Job 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
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