Sr Quality Specialist, Global Contract Manufacturing

Balchem Corporation; Montvale (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Balchem Corporation in Montvale, NJ is seeking a Sr Quality Specialist for Global Contract Manufacturing to govern quality and product safety across our external manufacturing network. You will lead qualification and ongoing performance management of co-manufacturers, ensuring compliance with Balchem's Quality Management System and regulatory requirements.

You will collaborate with R&D, Operations Quality, Procurement, and Commercial teams to drive supplier quality improvements, risk analyses,

Qualifications

• Bachelor’s degree in Food Science or related field.
• 3+ years experience with external manufacturers/suppliers in food, feed, or dietary supplements.
• Experience auditing Quality Management Systems and co-manufacturing facilities.
• Knowledge of HACCP, GMP, GSFI, and allergen/contaminant controls.
• Strong problem-solving and root-cause analysis skills.
• Excellent communication and cross-functional collaboration abilities.
• Willingness to travel up to 50%.
• Proficient with ERP and data analysis tools.

Responsibilities

• Lead development and governance of the Co-manufacturing Quality Management program.
• Ensure co-manufacturers comply with Balchem QMS standards.
• Manage qualification, onboarding, and ongoing performance of co-manufacturers.
• Act as primary quality authority for global co-manufacturing partners.
• Manage co-manufacturer audit program for qualification or incidents.
• Develop and present KPI on co-manufacturer quality performance.
• Support management reviews with data-driven recommendations.
• Manage change control for quality and product safety issues.
• Collaborate with Procurement, R&D for product innovation projects as Quality lead.
• Manage disposition and release of co-manufactured products.
• Conduct investigations and CAPAs to determine disposition for OOS.
• Identify root causes with co-manufacturers and implement CAPAs.
• Review quality performance with co-manufacturers regularly.
• Support other External Manufacturing Quality team members.
• Other duties as assigned.

Skills

Quality management

Root cause analysis

Cross-functional collaboration

Communication skills

Problem solving

Detail-oriented

Education

Bachelor’s degree in Food Science or related field

Tools

ERP systems

Auditing software

Job description

Company Overview

Balchem is committed to making the world a healthier place by delivering trusted, innovative, and science-based solutions for the health and nutritional needs of the world. Balchem employs approximately 1,400 employees worldwide who provide the service, quality, and technology that enables our customers to win with their customers. We have built a reputation for delivering results to all of our stakeholders. Founded in 1967, Balchem, a Maryland corporation, became a publicly-traded company in 1970 and is listed on Nasdaq under the symbol “BCPC.” Our corporate headquarters is located in Montvale, New Jersey, and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the U.S. and Europe. The Company consists of three business segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.

Position Summary

The “Sr Quality Specialist, Global Contract Manufacturing” is responsible for governing quality and product safety across Balchem’s external manufacturing network of contract manufacturers. This role ensures compliance with Balchem’s Quality management System, regulatory requirements, and customer expectations. This position plays a critical role in enabling business growth through comanufacturing while safeguarding product integrity, driving comanufacturer performance, and ensuring product quality in addition to auditing and qualifying co-manufacturers. The role works closely with cross-functional teams - including R&D, Operations Quality, Commercial, Operations, and Procurement to select, qualify, manage, and support comanufacturing sites, and serves as the central hub for comanufacturing quality activities.

Essential Functions

• Lead the development, implementation, and governance of the Comanufacturing Quality Management program at Balchem.
• Ensure comanufacturers manufacturers comply with Balchem Quality Management standards.
• Lead the comanufacturer Quality qualification, approval, onboarding, and ongoing performance management process.
• Act as the primary authority ensuring quality and product safety for global co-manufacturing partners, supporting both strategic (comanufacturer development, program deployment) and tactical (audits, issue resolution) activities.
• Manage the co-manufacturer audit program, including conducting audits for qualification or incident investigation.
• Drive visibility of co-manufacturer quality performance through KPI development, tracking, and presentations, as well as continuous improvement activities.
• Support management reviews with data-driven recommendations.
• Manage co-manufacturer change control process for quality-and product safety-related issues.
• Partner with Procurement, R&D, and project teams to support comanufacturing in product innovation projects, acting as the Quality lead for such projects.
• Manage the Quality disposition and release of co-manufactured products.
• Conduct investigations and risk analyses as needed to determine product disposition for OOS material.
• Work with co-manufacturers to identify root causes and ensure the implementation of appropriate and effective CAPAs.
• Conduct regular interactions with co-manufacturers to review quality performance and partner to address issues.
• Support other members of the External Manufacturing Quality team as needed.
• Other duties as assigned or necessary.

Requirements

• Bachelor’s degree in Food Science, Regulatory Affairs, Food Law, or a related field.
• Coursework or certifications in areas such as U.S. food regulations, Codex Alimentarius, foreign food regulations, PCQI, and HACCP.
• Minimum of 3 years of experience with external manufacturer and/or supplier quality in food, feed, or dietary supplement industry.
• Experience in auditing Quality Management Systems and co-manufacturing/supplier facilities.
• Understanding of Quality and product safety standards (e.g., HACCP, GMP, allergen and contaminant control, GSFI, FAMI-QS).
• Demonstrated problem-solving and root cause analysis skills.
• Ability to work as a key member of cross-functional teams, as well as with external partners.
• Strong computer proficiency skills, including word processing, spreadsheet creation, forms development, online research, and ERP usage.
• Strong communication skills, with the ability to clearly and proactively communicate complex data and technical information to internal and external stakeholders.
• Highly detail-oriented, with the ability to assess, interpret, and validate complex information with accuracy.
• Able to work in both office and non-office (i.e., plant) environments as required.
• Able to travel up to ~50%.

#PRM123

Balchem is committed to a workplace culture that values and promotes diversity, inclusion, equal employment opportunities, and a work environment free of harassment and hostility.

The expected salary range for this position is $70,000 - 90,000 a year.