Senior Manager, GMP Quality

Job not on LinkedIn

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏳ Contract/Temporary

🟠 Senior

👔 Manager

👻 Ghost score 10%

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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Sigma Systems

WebsiteLinkedInAll Job Openings

201 - 500 employees

📡 Telecommunications

⚡ Energy

☁️ SaaS

💰 $11M Venture Round - Tribold on 2009-01

Telecommunications • Energy • SaaS

Sigma Systems is a software company that provides cloud-native, API-driven BSS/OSS, product catalog, CPQ and order orchestration solutions for communications service providers and energy/utilities companies. It offers modular, TMF-compliant components and managed services — including AI-enabled automation and data-driven tools — to help operators modernize billing, monetization, and customer fulfillment processes with a SaaS and cloud-focused delivery model.

📋 Description

• Serve as the QA representative on cross-functional project teams • Communicate with Quality and Production departments at domestic and international contract manufacturing organizations and with 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 • Partner with CMC and Commercial Manufacturing to conduct technical transfers and validation of new or existing processes and products to domestic and international contract manufacturing organizations • Support commercial validation activities by reviewing validation protocols and reports • Ensure compliance with existing procedures and identify continuous improvement opportunities through SOP and compliance standard revisions • Author, review, and approve standard procedures and electronic systems as needed • Lead, author, review, and/or approve CMOs' Quality Events, Investigations, CAPA, Change Controls, and Complaints, including initiating them in SMPA's eQMS as needed • Interface with domestic and international suppliers in a timely manner • Serve as Person-in-the-Plant as needed • Author relevant sections of Annual Product Reviews by compiling data and metrics and making recommendations • Perform other duties as assigned

🎯 Requirements

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

🏖️ Benefits

• 6 Months Contract