Source Job

• Serve as system administrator and execution owner for all electronic GxP systems, maintaining validation and compliance throughout their lifecycle.
• Configure, maintain, and troubleshoot system workflows, user roles, and security models in platforms like MasterControl and Veeva.
• Support audits and inspections as a system subject matter expert, ensuring inspection-ready documentation and data integrity.

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation. The company provides millions of patients, government partners, and emergency responders with security and peace of mind, operating as a focused, execution-driven organization.

• Lead Quality Systems and Regulatory Affairs to ensure compliance with FDA, ISO 13485, and EU MDR.
• Optimize the electronic Quality Management System (eQMS) and drive sustainable process improvements.
• Serve as primary quality and regulatory representative during audits, inspections, and regulatory submissions.

CEFALY Technology develops medical devices for migraine relief. It is a growing organization that values quality, compliance, and mentorship.

• Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
• Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
• Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.

Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.

• Lead and oversee Commercial Quality operations across the Ergomed Group, including managing Quality Cost Grids and supporting bid activities.
• Act as a subject matter expert for GxP Commercial Quality, driving quality input into client proposals and presentations.
• Mentor and develop quality staff to enhance their competence and confidence in becoming subject matter experts.

PrimeVigilance is a specialized mid-size pharmacovigilance service provider with staff across Europe, North America and Asia. It values employee experience, well-being and a healthy work-life balance to nurture a high-quality client service environment.

• Provide expert support for real property systems of record on assigned task orders.
• Perform data quality checks, validate records, and support audit readiness.
• Strengthen the team's technical depth across DoD real property systems.

FWI provides expert support for DoD real property systems. It has been recognized as a 2024 and 2025 Top Workplace by the Washington Post, offering growth in a collaborative environment.

• Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, and technology-enabled care workflows.
• Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, and audit readiness.
• Partner with Product, Engineering, and Clinical teams to assess regulatory pathway, device classification, and QMS requirements for new software capabilities.

Cadence is a clinical AI company that delivers continuous, proactive care for older adults with chronic conditions. They operate as a full clinical care delivery organization with clinicians working alongside health system partners, helping Medicare save $2M a week.

• Leads writing and preparing clinical and regulatory documents for drug and device development.
• Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
• Develops knowledge of US and international regulations and participates in process improvements.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.

• Oversee all administrative, technical, operational, contractual, and financial components of a regional program.
• Enforce compliance with policies, manage staff scheduling, and conduct performance evaluations.
• Maintain communication with employees and executive management, and ensure quality control standards are met.

MVM, Inc. is a professional services firm providing support to government customers in counter-narcotics, criminal investigations, and national security. They have 2,500 employees across the US and emphasize their core values of Service, Support, and Success.

• Lead batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
• Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
• Mentor and develop junior QA staff and contribute to quality system improvements.

Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.

• Support the Quality Management System including SOPs, training, and CAPA processes.
• Coordinate and conduct internal audits, vendor audits, investigator site audits, and trial master file audits.
• Provide QA consultation and support to project teams, and manage quality issues and corrective actions.

Precision for Medicine is a Clinical Research Organisation that combines novel clinical trial designs with advanced biomarker and data analytics solutions. The company has a strong focus on rare diseases and oncology, with a global team and a culture that values employee contributions and collaboration.

• Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
• Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
• Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.