Director, Quality Management Systems

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 $700 million and a market cap exceeding $4.0 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
The Director Quality Management Systems is a member of the Balchem Corporate Quality team. The leader in this role will ensure that the Balchem Quality Management System provides the structure necessary to effectively communicate Balchem Quality expectations and demonstrate best in class Quality while supporting continuous improvement.
The successful individual in this role will have a demonstrated ability to build systems that function efficiently in different GXP regulated environments including supplements, food, feed, infant formula and be familiar with ISO systems for chemical manufacture.
Essential Functions

• Lead or participate in special project teams as required.
• Develop and manage standardized Quality Training programs for Supply Chain roles involved in product manufacturing e.g. GMP, HACCP, SPC etc..
• Leads Supply & Product Quality team and Product Stewardship
• Proven leader who works effectively with Supply Chain and cross functional partners to identify opportunities, implement improvements and deliver results through a focus on both people and processes.
• Works cross-functionally to develop Corporate SOPs as required to support Quality Policy/ Expectations, including communicating them through an effective and efficient document control system.
• Great communicator and technical writer with the ability to effectively transfer knowledge to others.
• Builds, maintains and leverages relationships cross-functionally to identify process improvement opportunities and facilitate their implementation. Uses effective negotiation skills to resolve conflict and drive alignment
• An effective leader of people able to provides coaching and constructive feedback in a timely manner
• GLP practices and controls including Lab proficiency testing program, method validation protocols, ongoing product stability/ shelf life verification etc.
• Design and manage Quality software strategy within the wider corporate programs. This includes ensuring that Quality and compliance requirements of Product Lifecycle Management and Management of Change (MOC) processes are established, efficient and documented, and implementation of an electronic data integrity verification program.

Success Criteria

• Regulatory compliance is assured and can be demonstrated in external audits and FDA inspections
• The impact of changes are assessed effectively, and changes are carried out in an organized and well documented manner
• Associates have the training to carry out the Quality and GMP aspects of their roles
• Key Performance metrics are achieved
• Customer feedback is used to improve product quality
• Plant floor has the information needed to make quality products efficiently and accurately
• The Corporate Quality systems enable effective and transparent conformance to expectations and process improvements.

Requirements

• Demonstrated excellent oral and written communication skills and possess good interpersonal skills. Must be an effective communicator, possess good listening skills and have effective presentation skills.
• Demonstrates the ability to make sound decisions based on data.
• Demonstrated working knowledge of cGXP requirements for Food, Feed, Supplements as well as good laboratory practices, testing methodologies and manufacturing practices as described in the Food Chemical Codex (FCC).
• Experience working in a manufacturing environment is a plus.
• Knowledge of drying, pasteurization, acidified foods would be beneficial in this role.
• A Master’s degree is preferred. Equivalent work experience may be considered in lieu of a Master’s degree.
• Knowledge of chemical manufacturing Quality systems is an asset.
• Bachelor’s degree in Food Science, Chemistry or related discipline with five to seven years of experience in Quality management.
• Demonstrated leadership experience within the field.
• Demonstrated ability to understand and organize complex technical data for communication and analysis, working knowledge of Statistical Process Control and process capability.
• Conversant in requirements of ISO, ICH Q7, Food, Feed Quality systems.
• Demonstrated ability to develop and optimize Quality Management Systems that effectively support Quality, Supply Chain, the Business and other cross-functional teams.

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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.