17 days old

Director, Quality

balchem
Bridgeton, MO 63044
  • Job Code
    130160114

COMPANY OVERVIEW:

Balchem Corporation develops, manufactures and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. Our corporate headquarters is located in New Hampton, New York, (Hudson Valley area) and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the US and Europe. Founded in 1967, Balchem is a publicly traded company (NASDAQ BCPC) with annual revenues over $640 million and a market cap exceeding $3.0 billion. The company consists of three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. Balchem employs over 1,400 people worldwide who are engaged in diverse activities, committed to developing the company into global market leadership positions. To learn more about our dynamic, stable and growing company, visit www.balchem.com

POSITION SUMMARY:

This position is responsible for coordinating all aspects of quality in a CFR GxP regulated environment. This individual will develop, analyze, and drive associated programs to ensure maximum production quality, compliance to the Quality Management System, and compliance with cGxP requirements while supporting the company's mission. This position will assist in the formulating of the overall quality strategy for the company to ensure applicable regulatory compliance.

The Director, Operations Quality (OQ) is responsible for leading a group of manufacturing Site Quality Teams and acting as the point person for the Business on Quality issues for their area of influence as well as ensuing compliance to regulatory requirements and quality and food safety standards. The OQ Director will create a strategic roadmap for their sites and drive the execution of tactical plans to move each site toward best in class.

This position has the responsibility to support their designated production facilities in relation to overall plant quality. This includes, but not limited to, product quality, overall environmental sanitation, release of products, internal auditing, and GMP compliance.

ESSENTIAL FUNCTIONS:

  • Ensure highly disciplined compliance with all regulatory and SunOpta defined food safety and sanitation standards, systems, procedures and practices to guarantee wholesomeness of product.
  • Provide guidance and direction to plant teams ensuring compliance with food safety and quality policies and procedures
  • Manage the plant quality assurance team activities including travel, plant audits, setting objectives, priorities, and issue management protocols and procedures
  • Provide resources for plant trials and utilize data to participate in the development of product specifications with R&D and the plant quality team.
  • Provide support for procurement, operations, marketing and sales regarding quality inquiries and complaints. Analyzes trends in complaints and develops action plans. Assures appropriate records and samples are retained on any issues investigated upon closure
  • Leads plant quality teams in the development, execution and tracking of partner corrective action plans that drive improved compliance, continuous improvement, and increased performance efficiencies
  • Perform/execute job duties keeping the company's commitment to quality in mind, supporting the department's mission, and by being a role model for GMP on the floor
  • Follow all Product safety practices and processes applicable to the department
  • Develop, implement, and maintain processes that ensure product manufactured is safe and meets or exceeds quality expectations defined within the QMS, the specific product specifications, and applicable quality agreements
  • Manage the internal audit process to confirm compliance to the QMS, with the expectation of creating and maintaining a state of audit readiness for both the system and overall facility within all company locations
  • Create and manage relationships with 3rd Party laboratories, consultants, and services that can support company initiatives
  • Work cross-functionally with the business to manage customer expectations and relations in the manufacturing of products. Ensure that customer requirements can be achieved reliably and cost effectively as part of the new product commercialization process.
  • Customer Quality agreements in collaboration with Supply & Customer Quality
    • Review and comment back to customer as needed. Ensure compliance can be achieved
    • Work with appropriate site QM to ensure requirements are updated in site quality systems
    • Create and maintain matrix of requirements by site and product and ensure it is part of change control etc. as appropriate
  • Establish and implement metrics for monitoring quality standards and departmental effectiveness
  • Define requirements for MOC (management of change) and commercialization system(s) in collaboration with R&D, Operations, D365, Engineering, Maintenance, Business, QMs
  • This role requires a mastery of the areas of Analytical thinking/ Problem solving, Decision Making, Prioritization, Collaboration, Coaching/ Mentoring, influencing others, Effective communication.
  • Prepare reports, analyze data, and make recommendations for improving operations
  • Provide mentoring and solutions to challenges for direct reports
  • Lead the effort in harmonizing the quality activities in all facilities
  • Initiate and support continuous improvement and elimination of waste and variation in processes using established improvement processes
  • Must develop cooperative relationships with other departments
  • All other duties as necessary to the success of Balchem Corporation

REQUIREMENTS:

  • Bachelor's Degree in a science related field and a minimum of 5 7 years of quality experience, including successful experience as a mid-level manage or equivalent level of experience
  • Proficiency in procedural and policy auditing, development, and implementation
  • Experience with at least one of the following, as appropriate for their role: 21 CFR 111 (Dietary Supplement), 21CFR 117 (food), 21CFR106 and 107 (infant formula), 21CFR 507 (animal food), 21 CFR 210 and 211 (pharma)
  • Successful track record of effectively managing and developing staff within an entrepreneurial environment
  • Demonstrated management skills including delegation, time management, leadership, and mentoring
  • Proven ability to work collaboratively with operations team
  • Communicates clearly, written and orally, with all levels within an organization, both internally and externally
  • Demonstrated ability to work with and develop others in a team environment
  • Clear sense of urgency and ability to manage priorities to meet both immediate and long-term goals
  • Self-motivated with the ability to work independently
  • Advanced computer skills, specifically with Microsoft Office products
  • Sensitive to other cultures/backgrounds, able to work in a multi-cultural workplace
  • Ability and willingness to learn, understand, and follow documented work procedures
  • Demonstrated ability to function in a fast-paced environment while moving multiple simultaneous projects forward

WORKING CONDITIONS:

  • While performing the functions of this job, the employee is regularly required to sit, stand, walk, talk, and hear
  • The employee may occasionally lift and/or move up to 50 pounds
  • Vision requirements include close vision, depth perception, color vision, and the ability to adjust focus
  • There will be exposure to machine noise and food dust when in the plant
  • While performing the duties of this job, the employee regularly works near moving mechanical parts and with or around various chemicals
  • Production environment includes varying temperatures (heat, cold and moisture)
  • While performing certain job duties, employees may be exposed to allergens of the industry such as eggs, wheat, peanuts, dairy products, tree nuts, and soy products, as well as latex and powders
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job; reasonable accommodations may be made to allow individuals with disabilities to perform the essential functions

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Posted: 2021-02-10 Expires: 2021-03-13

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Director, Quality

balchem
Bridgeton, MO 63044

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