Supplier Quality Engineer; Pharmaceuticals

Position: Supplier Quality Engineer (Pharmaceuticals)
Job Title:

Supplier Quality Engineer

Job Description

The Supplier Quality Engineer (Engineer, Supplier Quality III) ensures quality excellence and regulatory compliance across manufacturing operations in a highly regulated environment. This role supports inspection readiness, material movements, client audits, and supplier quality and material compliance activities, ensuring products consistently meet stringent standards while contributing to a mission of making the world healthier, cleaner, and safer. As part of the Supplier Quality Group, you will help maintain compliance with FDA, EMA, and other cGMP regulations, as well as specific client requirements, while fostering a culture of continuous improvement and operational excellence.

Responsibilities

+ Support site inspection readiness activities to ensure the facility and quality systems remain compliant with FDA, EMA, and other cGMP regulatory requirements, as well as client expectations.

+ Oversee and coordinate material movements to ensure that incoming materials and components meet defined quality and regulatory standards.

+ Participate in and support client audits and regulatory inspections, including preparation, facilitation, and follow-up on audit findings and commitments.

+ Work closely with suppliers to resolve supplier quality issues, including investigating nonconformances and implementing effective corrective and preventive actions.

+ Manage supplier-initiated change controls by assessing impact, coordinating internal reviews, and ensuring appropriate approvals and documentation.

+ Lead or support risk assessments related to supplier materials, processes, and changes, using formal risk management tools and methodologies.

+ Administer and manage Supplier Corrective Action Requests (SCARs), ensuring timely investigation, root cause analysis, corrective action implementation, and effectiveness verification.

+ Implement and maintain quality initiatives that enhance supplier performance, product quality, and regulatory compliance.

+ Support and enhance quality systems, including CAPA, deviation management, change control, risk management, and document control.

+ Conduct or support internal and external quality audits of suppliers and internal processes, documenting findings and driving closure of actions.

+ Oversee or support validation and qualification activities related to supplier materials, processes, and equipment, ensuring adherence to protocols and regulatory expectations.

+ Utilize electronic Quality and Training Management Systems to manage documentation, training, deviations, change controls, and related quality records.

+ Apply advanced problem-solving and root cause analysis tools to address quality issues and drive continuous improvement.

+ Collaborate with cross-functional teams, including manufacturing, engineering, procurement, regulatory, and quality control, to align on quality requirements and resolve issues.

+ Prepare, review, and maintain quality documentation, including procedures, reports, and records, to support a robust quality management system.

+ Use statistical analysis and quality tools to monitor supplier performance, analyze trends, and propose data-driven improvements.

+ Manage multiple projects and priorities, ensuring timely completion of quality-related tasks and initiatives.

+ Communicate effectively with internal stakeholders, suppliers, and external customers or regulators to convey quality expectations, findings, and resolutions.

+ Travel up to approximately 25% of the time, as needed, to support supplier audits, assessments, and quality-related activities.

Essential Skills

+ 7-10 years of experience in Quality Assurance with a BS degree in a STEM field, or an advanced degree plus at least 3 years of experience, or a bachelor's degree plus at least 5 years of experience in quality assurance within a regulated industry.

+ Background in pharmaceutical or medical device industries, with a strong preference for pharmaceutical experience; experience in a GMP or regulated environment is required.

+ Strong knowledge of cGMP and applicable regulatory requirements, including FDA, EMA, and other relevant guidelines.

+ Hands-on experience with quality management systems, including change control, root cause analysis, deviation management, documentation management, and training systems.

+ Experience using electronic Quality and Training Management Systems to manage quality records and training compliance.

+ Demonstrated expertise in CAPA and deviation management, including investigation, corrective action planning, and effectiveness verification.

+ Proficiency in change control processes, including impact assessment and implementation oversight.

+ Experience in risk management and FMEA methodologies for evaluating and mitigating quality risks.

+ Strong skills in document control, including authoring, reviewing, and maintaining controlled documents.

+ Experience conducting or supporting internal and external audits, including supplier audits and…