At Natrol LLC, we welcome and embrace creative and motivated talent to join a culture of innovation and inclusion where we value our employees and provide them the tools and environment to harness and cultivate change.
In support of our company’s principles, values, vision and mission, it is the mission of human resources to support the total operation in meeting its goals through its most valuable resource—its PEOPLE. Join our team! We have an immediate opening for an Associate Director of Quality Systems (ADQS) at our Chatsworth, CA office.
As the Associate Director of Quality Systems (ADQS), you will own the process to ensure that the Quality System requirements are established, implemented and maintained in accordance applicable standards.
You will oversee both the strategic and the day-to-day operation of the Quality Assurance, Quality Compliance and Compliance teams and will play a critical role in Safety Leadership. Ensures that all Natrol’s Safety, cGMP and regulatory requirements are met or exceeded. You are critical to help design and execute on the strategic direction of the organization. The individual is the senior leader for the operations team.
COMPETENCIES:
- Resource Allocation – includes management of people, schedules & machines to optimize the operation and meet the demands of cGMP, Safety, Maintenance and PTO. Supports order fulfilment (OTIF) while maximizing labor and machine efficiencies
- Technical Ability – includes ability to understand the technology of their department’s equipment, processes and SOPs. This involves both theoretical understanding and practical experience. This can include but not limited to equipment in laboratory, R&D, off-site testing labs and certain production equipment. Software applications such as SAP are relevant
- Process Improvement – Strong knowledge and execution of continuous improvement skills not limited to SPC, Six-Sigma, 5S, RedZone, HACCP and Advanced problem-solving techniques
- Quality – knowledge, practice and execution of cGMP, GLP and GDP skills
- Safety – understands, leads and executes safety concepts. Includes ongoing education, skills refinement and execution of safety related activities
Essential Responsibilities:
- Provide for strong leadership over the entire quality departmental staff
- Ensures that all departmental activities and projects are aligned with overall company goals and strategies
- Leads implementation and improvement of Natrol’s Quality Management Systems to ensure overall compliance to appropriate guidelines and regulations
- Review and approve Risk Assessments and Change Controls
- Quality oversight of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner
- Proactive identification of areas for process improvements and partnership with management to develop effective solutions that promote the company's business objectives
- Assists upper management in preparing and monitoring annual budget for capital and monthly expenditure of the department
- Perform analytical, statistical and trending analyses on relevant data to support timely management review and proactive response or corrective action reviews
- Monitors key metrics related to process and product efficiency
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Manage the recall process including initiation, customer and regulatory notification, and product withdrawal
- Reviews and approves vendor qualification documents
- Reviews specifications for raw materials, components and finished products
- Oversees hiring, performance, and development of department staff
- Provides Safety Leadership across multiple departments which may include design, training and enforcement of Safety related activities
- Manages compliance activities for other governing bodies (ie City Health)
Required Education and Experience:
- Bachelor's degree science or related field
- 10 years of experience in oversight of quality department
- Excellent written and verbal communication skills
- Knowledgeable in regulatory aspects of the dietary supplement industry
- Working knowledge of GMP, DSHEA, FDA and Proposition 65 guidelines
- Thorough understanding of problem-solving and quality improvement tools and techniques
- Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment
Supplemental Responsibilities:
This position is considered both ‘hands on’ and strategic. Time will be split between supporting the Quality teams, Production/facility discussions and developing / executing strategic initiatives. Broad technical knowledge of lab and some production equipment is required so they can recognize, correct and develop corrective actions both immediately and systematically. This position may provide backup support for the administration of the department staff including scheduling, employee timesheets, performance reviews, disciplinary reviews and other activities related to employee maintenance.
This position will be required to set and achieve production, safety, quality and budgetary goals in line with the Company’s guidelines and will work closely with other departments to meet productivity targets.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to fingers, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 30 pounds.
Travel:
Minimal travel of less than 20% may be required to visit customers, vendors or offsite training based on
business needs.
The Company will attempt to provide reasonable accommodations to an individual with disabilities.