POSITION SUMMARY:
The Director, Quality Systems - Global is a key member of the Balchem Corporate Quality team and have direct accountability for Balchem's Global Quality Systems, Corporate Quality Laboratory & Analytical Sciences, and Quality Performance Data & Analytics. 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 manufacturing.
ESSENTIAL FUNCTIONS:- Works cross-functionally to develop and deploy Corporate SOPs that meet industry standards, satisfy customer requirements, and comply with global regulations.
- Leads the Corporate Quality internal audit program that assesses the adherence to our internal systems, standards, and policies pertaining to quality, food safety, and regulatory compliance, while supporting the teams to develop and implement robust CAPAs associated with any identified gaps.
- Effectively collaborates with Supply Chain, Regulatory, Legal, and other cross functional partners to identify opportunities, implement improvements and deliver results through a focus on both people and processes.
- Assures consistent GLPs are in place and compliant at all global Balchem locations, including the Corporate Lab Proficiency Testing Program, method validation protocols, ongoing product stability/ shelf life verification, etc.
- Develops and manages standardized quality training programs for all Balchem employees at manufacturing locations, corporate headquarters, across all levels, etc. including topics such as GMP, HACCP, sanitation, allergens, etc.
- Develops and aligns the clear strategic direction for future priorities pertaining to Quality Systems to assure connectivity to the growth of the company, customer requirements, industry trends and best practices, and new technologies.
- Effectively communicates through verbal and written forms to various stakeholders internal and external to the company.
- Provides coaching, guidance, and support to direct report team, indirect functional employees, and cross-functional partners and stakeholders. This also includes subject-matter-expertise for technical topics, while also pertaining to leadership and cultural ways of working that fit with the company's values and principles.
- Design and manage Quality software strategies within the wider corporate programs. This includes the Quality Management System Platform, LIMs, MiniTab, and other software platforms.
- Lead or participate in special project teams as required.
REQUIREMENTS:- Bachelor's degree in Food Science, Chemistry or related discipline with a minimum of seven years of experience in Quality Leadership within various regulated industries (food, feed, pharmaceutical, nutraceutical, infant formula, dietary supplement, chemical manufacturing, etc.)
- Subject Matter Expertise in the space of Food Safety and Quality Systems, Regulations, Audit Schemes, SOPs/Standards, etc. to include various programs such as allergen control, labeling requirements, microbiological risks/mitigations (environmental monitoring, testing protocols, sampling plans, acidified foods, pasteurization, etc.), sanitation and hygienic design, internal/external auditing, GMPs, HAACP/preventive controls, traceability, pest control, etc.
- 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). Conversant in requirements of ISO, ICH Q7, Food, Feed Quality systems.
- Demonstrated ability to understand and organize complex technical data for communication and analysis, working knowledge of Statistical Process Control and process capability.
- Experience working in a manufacturing environment and engaging with stakeholders at all levels within corporate office environments, manufacturing environments, distribution centers and warehouses, etc.
- 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.
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