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Director, Quality Systems & Compliance
Ref No.: 17-00968
Location: Pleasanton, California
Start Date: 08/21/2017
POSITION SUMMARY
Director of Quality Systems & Compliance is a critical position for maintaining oversight of Quality Systems and Compliance, including global compliance programs, Facility Registrations, External Inspections, GMP training, Product Trending, Vendor Qualification/Audit program and Quality Metrics. Extensive knowledge of the Regulatory Compliance requirements for the Food, Drugs, Cosmetics and Dietary Supplements.


The position has significant compliance responsibilities and requires an individual with extensive knowledge of governmental regulations and communication skills to facilitate both FDA inspections of Facilities and Vendor Audits/Inspections. The position is also responsible for ensuring new product development meets quality standards, partnering with Research & Development to provide independent approval of trial results, prototype samples and finished good samples.

Additionally, the Director of Quality Systems & Compliance acts as an advisor to the QA staff in identifying and solving complex QA problems, supports new product development and launches, approves test plans and protocols, determines whether protocols meet minimum GMP standards, approves/rejects pilot batches based on a review of batch records/QC test results and provides technical/regulatory/QA/GMP assistance to our clients and customers. The Director of Quality Systems & Compliance partners with the cross functional groups to ensure a smooth transition to commercial production and batch release and provides guidance to any quality issue related investigations as needed.
 
ESSENTIAL JOB DUTIES:
  • Ensure GMP policies, SOP's standards and practices are established for all aspects of product development and manufacturing for each product category (food, dietary supplement, drug, cosmetic, etc.)
  • Establish and manage Quality Management System reviews to ensure visibility to quality and compliance metrics
  • Establish and monitor global compliance processes (CAPA, Internal/External Audits, Field Actions, Customer Complaints) 
  • Select teams, establish timelines and conduct qualification audits of potential suppliers and compliance audits of current suppliers, manufacturing and distribution facilities (internal and contract) and R&D facilities (internal and contract).
  • Communicate with federal and state agencies which regulate our products and license our facilities (FDA, DEA, EPA, etc.). Update and maintain all licenses and registrations.
  • Administer GMP training program, conduct training sessions as required and maintain training database.
  • Serve as partner to other functional areas, e.g., Research & Development and all functions within Operations.
  • Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments and reinforce continuous improvement principles
  • Direct the activities of the Quality Staff in Pleasanton, CA and Groveport, OH to ensure regulatory compliance for each product category (food, dietary supplement, drug, device, cosmetic, etc.) and high product quality; including;
  • Review and approve new and existing product ideas; participate in new product teams.
  • Review and approve/reject specifications/standards for raw materials, packaging components, products and manufacturing processes, as well as applicable SOPs.
  • Ensure the distribution of procedures, standards and specifications to all participating functions.
  • Review analytical and microbiological test methods and protocols to ensure they meet all industry and legal standards.
  • Review and approve/reject test results from R&D and Manufacturing Quality Control during product development.
  • Direct and provide leadership to the QA group responsible for the investigation of consumer complaints (PERs) related to quality failures and respond accordingly. Track and report PER trends to management.
  • In the event of a major quality failure with a distributed product, conduct in-depth investigation, notify senior management and initiate appropriate action (product hold/reject, market withdrawal or full recall).
  • Establish and monitor the CAPA programs at Contract manufacturers and facilities to ensure that all non-conformances are addressed and adequate corrective action is taken as necessary.
  • Approve/reject pilot plant/plant trial batches, and clinical batches (Kohl Center and contract manufactured).   
 
POSITION REQUIREMENTS:
  • Minimum of 10 years of balanced management and hands on experience in the Quality Assurance/Compliance functions of the FD&C industry (dietary supplements, food, drug and cosmetic). Product Development and all functions within Operations.
  • Bachelor's or Master’s degree in chemistry/microbiology/engineering.
  • Understanding of quality technology, ASQ certification (CQE or CQM) preferred.
  • Knowledge of GMP regulations for FD&C products and corresponding industry standards.
  • Practical understanding of statistical methods.
  • Extensive and effective management experience in R&D and Manufacturing environment and in interacting with Product Management, Legal and Field Support.
  • Strong technical expertise in the GMPs and other Regulations impacting FD&C industry.
  • Proven competence in dealing with internal processes and personnel.
  • Excellent critical thinking, strategic and analytical skills as well as a holistic approach to problem solving and decision-making.
  • Excellent organizational skills and ability to perform multiple, overlapping tasks.
  • Ability to effectively communicate with and persuade senior management.
  • Must possess excellent oral, written and listening skills.
  • Positive attitude and excellent interpersonal skills.
  • Proven competence in creating, administering and managing budgets.
  • Ability to analyze present processes to accurately predict and manage to future needs.
  • Understanding of network (or multilevel) marketing preferred.
  • Understanding of health and wellness industry.
  • Good physical health. Must be able to travel by car or air on short notice, and be able to access equipment in a plant environment.
  • Requires ability to resolve complex technical and regulatory issue and work long hours when necessary to support changing business requirements.
  • Knowledge of computers, word processing, spreadsheet and statistical programs.
  • Must work well with others.
  • Must work well under pressure.
 
 
 
Nate Shipman
Sr. Technical Recruiter
602-301-4623
nate@itavalon.com
www.itavalon.com
www.linkedin.com/in/nshipman
Avalon Staffing / IT Avalon / Avalon Finance / Avalon Healthcare Staffing
 
Recognition worth mentioning:
 
#12 Fastest Growing Private Company in the Bay Area – San Francisco Business Times
#5 Fastest Growing Private Company in the East Bay – San Francisco Business Times
#57 Largest Women-Owned Company in the Bay Area – San Francisco Business Times