Job Description

Job Summary

EMMA International, a leading consulting firm in the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries, is seeking a highly motivated and experienced Consultant to join our team. This role will focus on providing technical expertise to clients in the pharmaceutical manufacturing industry, specifically in supplier quality management, supplier audits, investigations, and compliance with regulatory requirements.

Essential Duties

• Provide technical expertise and support to clients in supplier quality management, including supplier audits, qualification, and risk assessments.
• Conduct thorough root cause analysis and recommend corrective and preventive actions (CAPAs) to address supplier-related quality issues.
• Develop, review, and enhance supplier-related documentation, including supplier agreements, quality agreements, audit reports, and supplier management procedures.
• Ensure compliance with FDA regulations, cGMP, ICH guidelines, and other global regulatory requirements related to supplier quality.
• Evaluate and improve supplier quality systems, ensuring robust change control, deviation management, and effective supplier performance monitoring.
• Implement Lean Six Sigma methodologies to enhance supplier processes and reduce non-conformances.
• Lead supplier audits and assessments, identifying gaps and driving remediation efforts in collaboration with suppliers.
• Effectively communicate findings and recommendations to clients and suppliers, presenting technical information in a clear and concise manner.
• Collaborate with cross-functional teams to drive continuous improvement initiatives in supplier quality management.

Qualifications

• 3+ years of experience in supplier quality management within the pharmaceutical, biotechnology, or life sciences industry.
• Strong understanding of cGMP, FDA regulations, ICH guidelines, and supplier quality best practices.
• Experience conducting supplier audits, managing supplier non-conformances, and leading supplier corrective actions.
• Lean Six Sigma certification, with a proven track record of driving process improvements related to supplier quality.
• Strong technical writing and communication skills, including experience drafting supplier quality agreements and audit reports.
• Expertise in risk assessment methodologies related to supplier qualification and ongoing monitoring.
• Ability to work independently and as part of a team, managing multiple supplier-related projects.
• Must have advanced experience with supplier investigations and issue resolution.
• Bio/Pharma industry experience preferred.

Education & Additional Requirements

• BA/BS in Biochemistry, Chemical Engineering, Biology, or a related scientific discipline.
• Willingness to work on-site at client facilities as needed.
• Experience working in a manufacturing or supplier quality environment, troubleshooting supplier-related issues.
• Availability to work various shifts as required to support supplier audits and compliance activities.

If you are passionate about supplier quality and are looking for an opportunity to work with a dynamic team of experts, apply today!

To apply, please send a cover letter and resume to careers@emmainternational.com .

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