Site Quality and Compliance Lead

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🔥 7 minutes ago

🦌 Connecticut – Remote

🦌 Connecticut – Remote

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Drive quality and compliance in the planning, preparation, conduct, and monitoring of Phase I-IV national and international clinical programs, Expanded Access Programs, Registries, and Survey trials • Develop and deliver CDO training programs and just-in-time training initiatives for the US CDO organization • Implement quality activities and support inspection readiness • Participate in global functional quality network initiatives • Plan and coordinate assigned training initiatives within timelines and financial targets • Support curriculum development by analyzing course materials and training methods across CDO roles • Collaborate with US CDO, Legal, and Med/RA functions to facilitate quality-related communication and execution • Assist with activities addressing findings from sponsor inspections and internal audits focused on CDO • Proactively identify, support, and assist in developing and implementing CD&O quality activities and inspection readiness • Perform assigned quality reviews, including review of BI processes • Act as primary point of contact for US CD&O non-compliances and collaborate on resolution • Execute coordinated CD&O quality activity programs • Participate in site non-compliance meetings and assist trial teams with CAPA plans • Serve as CAPA champion when required • Report quality metrics to assess trends, performance needs, and compliance issues • Identify potential risks and collaborate on risk mitigation strategies • Support onboarding to US CDO & Medicine and process improvement initiatives • Disseminate trends and lessons learned to the US CDO organization • Conduct business in accordance with applicable regulations and company policies • Maintain high ethical and professional standards in business contacts

🎯 Requirements

• Bachelor's degree, highly preferred in life sciences • Knowledge of pharmaceutical life cycle processes • Knowledge of regulatory requirements and compliance • Knowledge of technology trends • Project/program management knowledge • Current knowledge of and adherence to government regulations, including FDA, ICH, and GCP • Ability to gain knowledge of company SOPs, local working instructions, and role-specific training • Understanding of business/technical knowledge, communication, customer orientation, delivering results, external focus, fast and focused execution, innovation and change, planning and organization, quality orientation/business process excellence, teamwork and collaboration, and related competencies • Accountability and ownership • Integrity and trust • Commitment to values, diversity, and inclusion

🏖️ Benefits

• 24-month position duration • Training and professional development through developing and delivering CDO training programs • Collaboration with cross-functional partners and global functional quality networks

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