Principal Supplier Quality Engineer

Simtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to deliver sterile injectable products. The Principal Supplier Quality Engineer (SQE) will ensure that external suppliers meet the company's quality and compliance standards, focusing on supplier oversight, performance trending, and continuous improvement in alignment with global pharmaceutical regulations.

Responsibilities:

• Manage the supplier change notification lifecycle, including evaluation, risk assessment, approval, tracking, and closure
• Perform trend analysis of supplier quality data and proactively identify emerging risks
• Review, analyze, and report supplier trends, including effectiveness and sustainability of corrective actions
• Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues
• Identify, document, and close gaps between Supplier Quality practices and corporate and local procedures, ensuring regulatory and procedural compliance
• Guide and mentor peers in the application of statistically based quality engineering methodologies, including data analysis, interpretation of results, and risk‐based decision making
• Assess existing supplier quality processes and recommend improvements to enhance compliance, efficiency, and robustness
• Support supplier qualification, performance monitoring, and ongoing quality development activities, including on‐site and remote engagements
• Participate in supplier audits, quality reviews, and business reviews as required
• Ensure supplier quality activities comply with cGMP, global pharmacopoeias, and international regulatory expectations
• Prepare and maintain clear, concise, and compliant documentation, metrics, and reports for internal and external stakeholders

Requirements:

• Bachelor's degree required, preferably in a Science or Engineering discipline
• 3-4 years of experience in Quality, Manufacturing, or Engineering required; Supplier Quality experience strongly preferred
• Demonstrated experience in root cause analysis, application of quality tools, corrective and preventive action (CAPA) methodologies, and data analysis and reporting
• Strong knowledge of pharmaceutical regulations and international standards, including FDA cGMP, Eudralex, ISO 13485, ISO 9001, and global aseptic manufacturing regulations
• Proven ability to manage quality relationships with key suppliers, including coordination and leadership of on‐site and off‐site supplier quality development activities
• Project management skills, with the ability to manage multiple issues of moderate to high complexity independently with minimal supervision in a fast‐paced environment
• Business acumen, with an understanding of current and emerging industry trends, policies, technologies, and regulatory expectations
• Strong collaboration and teamwork skills, including effective communication, facilitation, and cross‐functional coordination
• Superior written and verbal communication skills, with the ability to clearly convey technical and regulatory requirements
• Willingness and ability to travel 30%–50%, including international travel
• Flexibility for a hybrid work environment (remote and on‐site), with routine visits to Bloomington, IN and/or Halle, Germany as required to support Simtra operations
• Supplier Quality experience strongly preferred
• Biopharmaceutical, pharmaceutical, medical device, combination product, and/or biologics industry experience highly preferred