JOB FILLED - Director of Quality

Job Description: 

The goal of Jarrow Formulas® is to promote optimal health with high-quality, effective, affordable, and superior formulation of dietary supplements. Our staff of scientists and health professionals are actively involved in clinical studies and continually work with researchers from universities and institutes around the world.

Jarrow Formulas is hiring a Director of Quality to support operations at the Santa Fe Springs / Chatsworth, California locations. As the Director of Quality, you will 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 Control and Compliance teams and will play a critical role in Safety & Training Leadership. Ensuring that all Safety, cGMP and regulatory requirements are met or exceeded.  Critical to help design and execute on the strategic direction of the organization.  You are a senior leader for the operations team and will manage multi-site operations at Chatworth, CA and Santa Fe Springs, CA.

You will communicate with all levels of personnel, customers and vendors.  Strong oral communication skills are required to establish interpersonal relationships across the organization. This position directly manages the Quality Operations department and reports to the VP of Manufacturing.

Essential Responsibilities:

  • Provide for strong leadership over the entire quality departmental staff across multi-site and multi-organization.
  • Ensures that all departmental activities and projects are aligned with overall company goals and strategies.
  • Designs, Develops and Leads improvements to the Quality Management Systems to ensure overall compliance to appropriate guidelines and regulations.  Includes all audits (internal, external) as well as 3rd party certification audits.
  • 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.
  • Provides preparation and monitoring of budget for capital and monthly expenditures.
  • 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.
  • Manages all Laboratories (internal / external) and LIMS infrastructure.
  • Reviews and approves vendor qualification documents.
  • Manages and Leads the Environmental Compliance and Environmental Leadership initiatives.
  • Works closely with R&D, Procurement, Operations, 3rd Party auditors.
  • Reviews specifications for raw materials, components and finished products.
  • Oversees hiring, performance, and development of department staff.

Supplemental Responsibilities:

  • Works closely with quality supervisors and leads to oversee the training program and compliance to Good Laboratory Practices and Good Manufacturing Practices.
  • Leadership in all health and safety programs.

Requirements:

Qualifications:

  • Bachelor's degree science or related field or MBA preferred
  • 10 years of experience in oversight of quality department
  • Detailed knowledge and experience with implementing a quality system that meets customer expectations relative to FDA (including GMP) standards. Working knowledge and experience with ISO 9001 and/or ISO17025 is essential
  • Extensive knowledge of GMP, DSHEA, CFR, FDA and Proposition 65 guidelines
  • Proven leader who works with a sense of urgency and acts as a good team player working with other disciplines; demonstrated ability to lead, teach and develop individuals to higher levels of performance
  • Demonstrated ability to synthesize data from various sources to identify trends and opportunities 
  • Demonstrated success in deploying quality methodologies such as: supplier quality audits/improvement plans, and troubleshooting and corrective action with a clear record of resulting business improvement
  • Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees
  • Experience in conducting and managing customer and regulatory body quality audits, with customers is preferred
  • Demonstrated ability to drive significant culture change
  • Demonstrated ability to create the Quality and Environmental System strategies for an organization with proven results
  • Demonstrated ability to deploy Quality, Methodical and Innovative methodologies to deliver business improvements
  • Knowledgeable in regulatory aspects of the dietary supplement industry
  • 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

Physical Conditions: 

You must be able to stand for periods of time while performing various physical and analytical tests. Will work around powders and other chemicals.

The Company will attempt to provide reasonable accommodations to an individual with disabilities.

Compensation/Salary: 
$130k - $165k DOE
Category: 
Last Resume Date: 
Tuesday, June 29, 2021 - 11:50am