Senior Compliance & Quality Assurance Consultant
New
Based in the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 10+ years
- Required Skills
- Quality Assurance
Requirements
- 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.
Responsibilities
- 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.
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