Senior Manager, GMP Quality Assurance

🔥 5 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $138k - $190k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Lead batch release activities, including review/approval of batch records and material disposition • Provide GMP oversight for manufacturing and distribution partners (DS, DP, and supply chain) • Ensure compliance with global regulations (FDA, EMA, ICH) • Manage investigations, deviations, CAPA, and change controls • Support audits, inspections, and annual product reviews • Drive quality system improvements and track key quality metrics • Partner with CMOs and suppliers on validation, tech transfer, and qualification activities • Mentor and develop junior QA staff

🎯 Requirements

• Bachelor’s degree in life sciences, chemistry, or related field • 8+ years of GMP Quality experience in pharma or biotech • Strong knowledge of global GMP regulations and quality systems • Proven ability to lead cross-functional initiatives and solve complex problems • Excellent communication and stakeholder management skills. • Experience with eQMS (e.g., Veeva) and global markets is a plus. • Must be authorized to work in the U.S.

🏖️ Benefits

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.