Director, Quality Management Systems
Company: balchem
Location: Montvale
Posted on: May 26, 2023
Job Description:
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
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:
- 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.
- GLP practices and controls including Lab proficiency testing
program, method validation protocols, ongoing product stability/
shelf life verification etc.
- 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
- 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.
- 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
- Lead or participate in special project teams as required.
Success Criteria
- Regulatory compliance is assured and can be demonstrated in
external audits and FDA inspections
- Plant floor has the information needed to make quality products
efficiently and accurately
- 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
- The Corporate Quality systems enable effective and transparent
conformance to expectations and process improvements. REQUIREMENTS:
- 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.
- A Master's degree is preferred. Equivalent work experience may
be considered in lieu of a Master's degree.
- Experience working in a manufacturing environment is a
plus.
- Demonstrated ability to develop and optimize Quality Management
Systems that effectively support Quality, Supply Chain, the
Business and other cross-functional teams.
- 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).
- Demonstrated ability to understand and organize complex
technical data for communication and analysis, working knowledge of
Statistical Process Control and process capability.
- 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.
- Conversant in requirements of ISO, ICH Q7, Food, Feed Quality
systems.
- Knowledge of chemical manufacturing Quality systems is an
asset.
- Knowledge of drying, pasteurization, acidified foods would be
beneficial in this role.
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.
PI
Keywords: balchem, Tenafly , Director, Quality Management Systems, Executive , Montvale, New Jersey
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