Senior Quality Specialist

Katalyst CRO; Parsippany-Troy Hills (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Specialist to ensure NA products manufactured at third party contract sites comply with regulations and corporate quality standards throughout their lifecycle.

You will interface with multiple teams, guiding quality requirements for qualification and maintenance of external manufacturers and suppliers, and supporting continuous improvement at existing sites. The role emphasizes audits, CAPA, and supplier qualification across a fast-paced environment.

Qualifications

• BA or BS in engineering, life or natural sciences.
• Experience with ISO 9000, GMP, HACCP and auditing.
• 10+ years in QA/QC within a regulated environment.
• Detail-oriented, proactive, and adaptable.
• Strong teamwork and communication skills.
• Travel availability around 20–30% for Midwest/East Coast work.

Responsibilities

• Provide quality lead for external manufacturing activities, investigations, questions, and complaints to ensure project and product success.
• Collaborate with Supply to ensure development stages meet Quality corporate requirements.
• Prepare quality documentation for launches and changes (manuals, agreements, certificates).
• Perform Quality risk assessments for external manufacturing operations.
• Represent QA during trials and validation at external manufacturers.

Skills

Quality Assurance

Auditing

GMP knowledge

Documentation

Communication

Travel readiness

Education

BA/BS in engineering, life sciences, or natural sciences

Job description

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.

• 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.

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.

• 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.

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.