Senior Manager, Quality Systems, Compliance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $152k - $190k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Assist in leading activities within Quality Systems and Compliance • Design and implement a Quality Management System supporting clinical development programs and the growing pipeline • Execute and support ongoing QMS effectiveness • Manage deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks • Work with external partners and suppliers/vendors on quality activities • Create controlled documents and governance frameworks for core processes and continuous improvement • Support regulatory compliance within drug production activities • Execute a quality roadmap translating regulatory and quality requirements into scalable operating models • Identify and mitigate compliance risk through data-driven monitoring • Foster accountability, transparency, and quality ownership across the organization • Provide quality oversight and coordination for internal and third-party audits • Prepare U.S.-based and global clinical programs for inspection readiness • Partner with Regulatory, Medical, Clinical, R&D, and Technology leadership

🎯 Requirements

• Bachelor’s degree in a scientific or technical field, such as biology, chemistry, engineering, or related health science • 6+ years of progressive Quality experience within a GxP-regulated industry • Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration • Experience managing, implementing or improving a Quality Management System • Experience implementing and maintaining electronic quality management systems (eQMS) such as Veeva, ZenQMS, or MasterControl • Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations • Working knowledge of GCP and applicable GMP principles as they relate to quality systems • Strong understanding of risk-based quality systems and continuous improvement concepts • Experience partnering and leading cross-functional teams, including Regulatory, CMC, Clinical Operations, Information Technology and R&D • Strong technical writing, organizational, and problem-solving skills • Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes • Must be currently authorized to work in the United States • Must answer whether visa sponsorship is required • Must have experience managing a validated eQMS

🏖️ Benefits

• Company paid healthcare • Flexible spending accounts • Voluntary life insurance • 401K matching • Uncapped vacation • Onsite gym • Dining at the San Diego facility • Flexible remote or hybrid work arrangement