[Hiring] Site Quality and Compliance Lead @Sigma Systems, Inc.

Role Description

The Site Quality and Compliance Lead is fundamental to driving the quality in and the compliance of the planning, preparation and conduct, including monitoring of clinical programs for Phase I-IV national and international trials, Expanded Access Programs, Registries and Survey trials across Clinical Development Operations (CDO). The lead also plays a critical role in developing and delivering CDO training programs effectively.

• Responsible for implementation of quality activities and inspection readiness.
• Participates in and contributes to global functional quality network initiatives.
• Ensures Quality activities are conducted in compliance with governmental regulations (i.e., FDA/ICH/GCP), company SOPs, and local working instructions, while adhering to financial targets.
• Develops and delivers just-in-time training initiatives to the US CDO organization.
• Plans and coordinates assigned training initiatives to ensure timely delivery of high-quality project outcomes.
• Supports curriculum development by analyzing course materials and training methods across CDO roles.
• Collaborates with cross-functional partners in US CDO, Legal, and other Med/RA functions to drive quality in clinical programs.
• Works with Quality Medicine and other partners to address findings related to sponsor inspections and/or internal audits.
• Identifies, supports, and assists in the development and implementation of CD&O Quality activities and inspection readiness.
• Acts as primary point of contact for US CD&O non-compliances for triage to Quality Medicine partners.
• Maintains working partnership with Quality Medicine and cross-functional partners.
• Participates in site non-compliance meetings to assist trial teams in developing Corrective and Preventive Action (CAPA) Plans.
• Executes the reporting of quality metrics to assess quality trends and compliance issues.
• Supports execution of onboarding to US CDO & Medicine and process improvement initiatives.
• Ensures trends or lessons learned are disseminated to the US CDO organization on a routine cadence.
• Performs all company business in accordance with all regulations and company policy and procedures.

Qualifications

• Bachelors Degree (Highly preferred in life sciences)

Requirements

• Knowledge of Pharmaceutical Life Cycle Process - Level 3 - Influencing
• Knowledge of Regulatory Requirements & Compliance - Level 3 - Influencing
• Knowledge of Technology Trends - Level 2 - Demonstrating
• Project/Program Management - Level 3 - Influencing
• Business/Technical Knowledge - Level 2 - Demonstrating
• Communication - Level 3 - Influencing
• Customer Orientation - Level 2 - Demonstrating
• Delivering Results - Level 3 - Influencing
• External Focus - Level 2 - Demonstrating
• Fast and Focused Execution - Level 3 - Influencing
• Innovation and Change - Level 2 - Demonstrating
• Planning and Organization - Level 2 - Demonstrating
• Quality Orientation/Business Process Excellence - Level 3 - Influencing
• Lives Lead & Learn - Level 2 - Demonstrating
• Teamwork and Collaboration - Level 3 - Influencing
• Winning Vision - Level 3 - Influencing
• Growing Talent - Level 2 - Demonstrating
• Managing Performance - Level 2 - Demonstrating
• Accountability and Ownership
• Integrity and Trust
• Values Diversity and Inclusion
• Current knowledge in and adherence to government regulations (eg., FDA, ICH, GCP) and ability to gain knowledge of company SOPs, Local Working Instructions and role specific training.