Site Quality and Compliance Lead

Magnit; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Magnit is seeking a Site Quality and Compliance Lead to drive quality and ensure compliance with FDA/ICH/GCP across Phase I-IV trials, Expanded Access Programs, Registries and Survey trials within Clinical Development Operations. The role includes developing training programs and coordinating quality activities across CD&O.

You will lead inspection readiness, CAPA development, risk mitigation, and collaboration with Legal, Med/RA, and cross-functional partners to address findings and drive

Qualifications

• Current knowledge of FDA, ICH, GCP regulations.
• Bachelor’s degree in life sciences preferred.
• Experience in clinical development operations quality activities.
• Ability to work with cross-functional teams.

Responsibilities

• Drive quality activities and inspection readiness across CD&O.
• Develop and deliver just-in-time training within US CDO.
• Lead CAPA and risk mitigation for trial findings.
• Collaborate with Legal, Med/RA and cross-functional partners.
• Report quality metrics and support onboarding and process improvements.

Skills

Regulatory knowledge

Project management

Quality assurance

Communication

Education

Bachelor's Degree (Life Sciences preferred)

Job 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.

The Lead is responsible for implementation of quality activities and inspection readiness. As directed by Team Lead, participates in and contributes to global functional quality network initiatives. The Site Quality and Compliance team as a whole ensures Quality activities are conducted in compliance with governmental regulations (i.e., FDA/ICH/GCP), company SOPs, and local working instructions, and business ethics while adhering to financial targets.

The Lead will develop and deliver just in time training initiatives to the US CDO organization.

This role plans and coordinates assigned training initiatives to ensure timely delivery of high-quality project outcomes within set timelines and financial targets. The Lead supports curriculum development by analyzing course materials and training methods across CDO roles.

The Lead delivers on their tasks by working in collaboration with cross-functional partners in US CDO, Legal, and other Med/RA functions to facilitate the communication necessary to drive the quality in the planning, preparation and conduct, including monitoring of clinical programs, and execution of quality activities across Clin Ops.

Works in collaboration with Quality Medicine and other cross-functional partners to assist in activities addressing findings related to sponsor inspections and/or internal audits focused on CDO.

Proactively identifies, supports and assists in the development and implementation of CD&O Quality activities and inspection readiness. Perform quality reviews, as assigned, including review of BI processes.

Act as primary point of contact for US CD&O non-compliances for triage to Quality Medicine partners. Collaborate for resolution.

Maintain working partnership with Quality Medicine, cross-functional partners in rest of CD&O, Legal, and other Med/RA functions. Executes coordinated programs of CD&O Quality activities based on common goals and objectives.

At direction of Team Lead, participates in and contributes to global functional quality network initiatives

Participate in site non-compliance meetings, as appropriate to assist trial teams in the development of Corrective and Preventive Action (CAPA) Plans. Serve as CAPA champion, as required.

Executes the reporting of quality metrics to assess quality trends, individual performance needs and/or compliance issues. Identify potential areas of risk and collaborate with CD&O team members in establishing risk mitigation strategies.

Support execution of onboarding to US CDO & Medicine, process improvement initiatives, including training programs to address quality and/or performance issues.

Ensures trends or lessons learned are disseminated to the US CDO organization on a routine cadence.

Perform all company business in accordance with all regulations (EEO, FDA, ICH, DEA, OSHA, PDMA, PhMRA, etc.) and company policy and procedures. Demonstrate high ethical and professional standards with all business contacts in order to maintain BIPI’s excellent reputation within the medical and pharmaceutical community.

Functional Competencies

• 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

Core Competencies

• 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

Management Competencies

• Growing Talent - Level 2 - Demonstrating
• Managing Performance Level 2 - Demonstrating

Foundational Competencies

• 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.

Bachelors Degree (Highly preferred in life sciences)