GMP Quality Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Global Channel Management, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

🎯 Recruiter

☁️ SaaS

Consulting • Recruitment • SaaS

Global Channel Management, Inc. is a technology company that specializes in recruiting and staff augmentation services. With over a decade of experience, their account managers and recruiters help organizations address challenges in acquiring skilled talent, manage fluctuating skill needs, and reduce training and labor costs. They focus on providing companies with the best talent to meet various staffing needs and timelines across different verticals.

📋 Description

• Serve as the QA representative on cross-functional project teams • Communicate with Quality and Production departments at domestic and international contract manufacturing organizations • Collaborate within SMPA's Quality, Supply Chain, CMC, and Commercial Manufacturing departments • Conduct product release activities for clinical and commercial drug substances and drug products • Review and approve Master Batch Records, Executed Batch Records, release and stability testing documentation, and batch disposition • Complete release activities in a timely manner to ensure continued product supply while ensuring product quality and safety

🎯 Requirements

• 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry and most experience in a Quality role • Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products • Experience managing external CMOs, contract laboratories, and third-party logistics suppliers • Experience reviewing and approving master and executed batch records and performing final disposition of drug substances and products • Experience managing quality events, including investigations, CAPA, and change control • Working knowledge of formal risk management tools and assessments • Ability to evaluate and assess technically complex quality events • Excellent technical writing skills • Experience evolving GMP-related quality systems, policies, and procedures to ensure compliance with evolving standards and improve workflow efficiency • Strong ability to analyze complex issues and develop relevant, realistic plans, programs, and recommendations • Excellent verbal and written communication skills, including ability to interact effectively with senior management, partners, and project core team members • Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment while maintaining a high level of quality and compliance • Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or relevant field of study