Sr Quality Specialist, Global Contract Manufacturing

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 comanufacturing 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%.

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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.