Science|Senior Quality Specialist,Science,Science|Quality Assurance Scientist Jobs

Summary :

This Senior Quality Specialist will be responsible for ensuring that NA products manufactured at third party contract sites comply with all the applicable regulations as well as with our corporate quality standards during their whole life cycle. This professional will interface with several areas and will work closely with the Supply teams providing guidance on the quality requirements for the qualification and maintenance of new, existing external manufacturers and suppliers. The role would support continuous improvement efforts at existing manufacturing sites.
Roles & Responsibilities :

• Provide quality lead for all external manufacturing related activities and suppliers, the resolution of investigations, questions or complaints, and ensuring end-to-end success of projects and products.
• Partner with the Supply teams in assuring that the stages of the development process comply with all our Quality corporate requirements
• Analyze and prepare Quality documentation for the launch of new products and for the change of the existing ones, such as technical manuals, technical agreements and good for sale certificates.
• Perform Quality risk assessments for new and existing external manufacturing operations.
• Act as Quality representative during trials and validation activities at external manufacturers.
• Lead the scheduling, execution, reporting and tracking of onsite audits of external manufacturers and suppliers to confirm that these operations are performed in compliance with EH's Global QMS and meet all relevant regulatory requirements.
• Maintain quality system processes and establish a supplier qualification program (such as Change Control, Supplier Management, Deviations and Investigations, CAPA, and others as needed).
• Track audit findings for suppliers to completion and ensure timely closure of audit reports and ensure adequate CAPAs are developed by external manufacturers, suppliers and monitor their closures.
• Analyze errors and deviation from process and procedures, hold key stakeholders accountable, and provide guidance on key actions and steps required to correct deviations.
• Interfaces with Supply and Procurement leadership for escalation of quality issues.

Required Qualifications :

• Minimum of a BA or BS degree, preferably in engineering, life, or natural sciences.
• Experienced in quality systems, such as ISO 9000, GMP, HACCP, and Auditing.
• 10+ years' experience in Quality Assurance / Quality Control Systems in a regulated environment.
• Must be quality-focused and detail-oriented.
• Must possess a high level of strategic mindset, proactive ownership, initiative and adaptability necessary for a fast-paced and founder driven environment.
• Must possess the competence to perform tasks requiring analytical and problem-solving skills.
• Must demonstrate outstanding teamwork in interacting with other team members.
• Excellent written and verbal communication skills, problem-solving, decision-making skills, and computer proficiency.
• Experienced in Good Manufacturing Practices.
• Experienced in quality systems, such as ISO 9000, GMP, HACCP, and Auditing.
• Experience conducting audits including planning and follow-up on CAPAs resulting from the findings.
• Travel required (approx. 20-30%), intermittent and planned, localized to Midwest and East Coast, and may likely go down over time.

Summary :
We are seeking a Senior Quality Specialist with 10+ years of experience in Quality Assurance and Quality Systems within regulated environments. The ideal candidate will have strong expertise in GMP, supplier quality, external/contract manufacturing, CMO oversight, audits, CAPA, deviation management, risk assessment, and change control. This role will provide Quality oversight of suppliers and third-party manufacturers while ensuring compliance with applicable Quality Management Systems and regulatory requirements. The candidate will collaborate closely with Supply Chain, Procurement, Manufacturing, Regulatory, and Quality teams to manage supplier performance, quality issues, audits, technical agreements, and continuous improvement initiatives.

Roles & Responsibilities:

• Provide Quality oversight for External Manufacturing, Contract Manufacturing Organizations (CMOs), and third-party manufacturers to ensure compliance with GMP, Quality Agreements, and company quality standards.
• Manage supplier qualification, approval, monitoring, and ongoing supplier performance through risk-based assessments, audits, quality metrics, and corrective actions.
• Plan, coordinate, and execute supplier/CMO audits, including audit preparation, execution, reporting, observations, and CAPA follow-up to closure.
• Lead and support deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks.
• Perform quality risk assessments related to suppliers, manufacturing processes, materials, changes, deviations, and quality events.
• Develop, review, and maintain Technical Agreements, Quality Agreements, SOPs, specifications, and other GMP quality documentation.

Education & Experience:

• Bachelor's degree in engineering, Life Sciences, Natural Sciences, or related field
• 10+ years of Quality Assurance and/or Quality Systems experience in regulated environments
• Experience supporting External Manufacturing and Contract Manufacturing Organizations (CMOs)
• GMP/Good Manufacturing Practices expertise
• Supplier Qualification and Supplier Management experience
• Audit Planning, Execution, Reporting, and CAPA Follow-Up
• Deviation Investigation and CAPA Management experience
• Risk Assessment experience
• Technical Agreements and Quality Documentation experience
• Change Control Management experience
• Strong cross-functional collaboration with Supply Chain, Procurement, and Manufacturing teams
• Quality Systems experience (GMP, ISO, HACCP)