Senior Compliance & Quality Assurance Consultant in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Compliance & Quality Assurance Consultant based in the United States.

This is a senior-level consulting role focused on ensuring regulatory excellence and quality compliance across complex life sciences programs, including pharmaceuticals, biotech, and medical devices. You will act as a trusted Subject Matter Expert in GxP and quality assurance systems, guiding clients through regulatory expectations and helping them implement robust, risk-based compliance frameworks. The role blends hands-on advisory work with strategic project leadership, including audit execution, CAPA development, and quality system design. You will collaborate directly with client organizations to strengthen operational quality, resolve compliance challenges, and support regulatory readiness across the full product lifecycle. In addition to client delivery, you will contribute to business growth through pre-sales support, SME input, and thought leadership activities. This is a highly autonomous role suited to an experienced consultant who thrives in regulated environments and enjoys solving complex compliance challenges with measurable impact.

• Serve as a Subject Matter Expert in GxP, quality assurance, and regulatory compliance, providing independent consultation and strategic guidance across client engagements.
• Lead and manage compliance and quality assurance projects, ensuring successful delivery, profitability, and alignment with client regulatory requirements.
• Conduct and lead GxP audits, including preparation, execution, reporting, and follow-up, ensuring adherence to global regulatory standards.
• Support the development, implementation, and improvement of Quality Management Systems (QMS), including SOP writing, training, and process optimization.
• Provide expert guidance on deviations, non-conformances, and CAPA development to ensure effective resolution and continuous compliance improvement.
• Participate in client engagement and pre-sales activities by defining scope, effort estimation, and contributing SME insights to proposals and solutions.
• Deliver training, workshops, and knowledge-sharing sessions for clients and internal teams on compliance, regulatory expectations, and quality best practices.
• Contribute to thought leadership and business development efforts through presentations, publications, and industry-facing content.

• Bachelor’s degree in a scientific discipline (minimum), with a Master’s or PhD preferred.
• 10+ years of experience in quality assurance, regulatory compliance, or GxP consulting within life sciences (pharma, biotech, or medical devices).
• Strong expertise in US FDA, EMA, ICH, and MHRA regulations and guidance frameworks.
• Proven experience leading GxP audits, including audit planning, execution, reporting, and follow-up activities.
• Deep knowledge of Quality Management Systems (QMS), CAPA processes, deviations, and compliance frameworks.
• Strong ability to manage multiple consulting engagements and deliver high-quality outcomes under time-sensitive conditions.
• Excellent communication skills, with the ability to influence clients and stakeholders through clear written and verbal communication.
• Strong analytical, organizational, and problem-solving skills with high attention to detail.
• Willingness and flexibility to travel as required for client engagements.
• Preferred: experience in QC laboratory environments (especially analytical/chemistry labs) and prior leadership experience in consulting or business unit management.

• Competitive senior-level consulting compensation package
• Opportunity to work across leading biotech, pharma, and medical device organizations globally
• Exposure to high-impact regulatory and quality transformation projects
• Flexible and hybrid working arrangements depending on client needs
• Professional development opportunities in advanced GxP, regulatory strategy, and quality systems
• Collaborative and inclusive work culture focused on expertise, autonomy, and continuous improvement
• Travel opportunities tied to client engagements