Quality Assurance & Postmarketing Surveillance Manager
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POST DATE 9/17/2016
END DATE 11/30/2016
Red Bull North America
Santa Monica, CA
JOB DESCRIPTIONThis position will develop, implement, manage and measure effective postmarketing surveillance and quality programs for Red Bull North America (U.S. and Canada). This role will ensure full compliance with the FDA Food Safety Modernization Act (FSMA) and Canadian regulations. The QA Manager will manage the performance of the program and will provide reporting to the global headquarters in Europe. This position is responsible to consolidate food safety issues and will therefore work closely with the logistics team, the legal regulatory and scientific department as well as the customer service department in the U.S.
AREAS THAT PLAY TO YOUR STRENGTHS
(ALL THE RESPONSIBILITIES WE\'LL TRUST YOU WITH)
* Location Santa Monica, California, United States
* Schedule Full-time
* Organisation Red Bull North America
QUALITY COMPLAINT MANAGEMENT AND POSTMARKETING SURVEILLANCE PROGRAM (U.S. AND CANADA)
Responsible to managing the product complaint program
Serve as the single point of contact for all product and quality complaints in North America
Partner with key company stakeholders on escalated customer quality care inquiries (i.e. foreign matters, potential defects, etc.)
Responsible for the Post Marketing Surveillance program
Partner with Regulatory and Scientific Affairs to define actionable steps in regards to product data
Responsible to establishing, monitoring, reporting and correcting key quality metrics
Product incident team coordinator
MEDICAL AFFAIRS MANAGEMENT
Partner with Regulatory, Scientific Affairs, and Risk Management to evaluate escalated cases to ensure compliance with U.S. and Canadian regulatory laws
Measure, categorize, analyze, evaluate, and report the frequency of consumer complaints in regard to health issues
Develop, implement and manage standard operating procedures (SOP s) to ensure compliance with U.S. and Canadian regulations
Be a subject matter expert and implementation manager of FSMA, including the Foreign Supplier Verification Program
Proficient in managing the execution of recalls, food defense programs, continuous improvement programs, etc.
SAMPLING PROGRAM MANAGEMENT
Serve as the single point of contact for routine collection and assessment of field samples in North America
CERTIFICATES / SPECIFICATIONS
Serve as the single point of contact for global Quality Management / Quality Control for the issuance and management of certificates (i.e. Kosher, Halal, certificates of analysis, SOPs, etc.)
Serve as the single point of contact for global QM / QA for manufacturing specifications, packaging specifications, and general supply chain management for ingredient quality/safety.
Partner with Operations and Distribution to implement and maintain a third party audit system for North America's supply chain
Cooperate with distribution and retail partners on QA and related topics, as required
YOUR EXPERIENCE INCLUDES:
(PROVEN PERFORMANCE IN)
* Minimum of 5-7 years of Quality and Post Marketing Surveillance experience in the area of Food Safety, Dietary Supplement or Pharmacy * Experienced with HACCP/HARPC, food processing and manufacturing * Experience with statistical analysis of manufacturing and production is mandatory * Experience authoring SOPs and food safety/quality manuals mandatory * Ability to manipulate and maintain databases to track deadlines, correspondence and agreements * Experience maintaining strict confidentiality of data and information * Must be proficient in Microsoft Word, Excel, PowerPoint * Track record of cross-functional collaboration and building strong relationships with internal and external stakeholders and advisors (including lawyers, Operations, Scientists, Public Affairs, Communications, etc.), in both, the U.S. as well as in other countries * Detail oriented and able to manage multiple projects with ease and measureable outcomes * Excellent written and interpersonal communication skills - ability to work effectively with executive management, employees, and vendors * Self-starter with track record of completing assigned tasks and projects without prompting * Strong sense of responsibility and ownership
Bachelor s Degree in in Human Biology, Microbiology, Toxicology, Food Science/Technology or related field
Fluent in English, French language skills an advantage
Red Bull North America is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, age, or any other classification protected by Federal, state, or local law.