Quality Assurance Manager - FDA regulated

Food, Beverage, Medical Device or Pharmaceutical Experience required - MUST HAVE "FDA" Experience

Position Summary :

The Quality Assurance Manager is the subject matter expert for scientific, regulatory, technical, food safety and / or quality related to Company.

This position establishes Quality and Reliability standards for the company. The Quality Assurance Manager follows up on consumer complaints, product recalls and product quality-related issues.

This position focuses on compliance through capability building. The Quality Assurance Manager oversees the review and mitigation of quality system failures, non-conformances, and incidents where risk mitigation is required.

This position achieves financial objectives related to Quality.

Position Responsibilities may include, but not limited to :

• Lead the Quality Authorization process for the company’s Manufacturing Plants
• Analyze metrics to demonstrate compliance to company requirements
• Drive corrective action and continuous improvement initiatives to mitigate risk and meet system goals
• Provide information to senior management for decision making during a crisis situation
• Review audit results and identify the severity of audit findings or the risk associated with the findings to ensure the appropriate level of action is taken to eliminate non-conformance
• Support customers and business partners to identify, manage and / or resolve incidents in order to maintain product integrity, trademarks and minimize interruptions to the company or customer operations
• Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted questions from the field or other departments and providing support to other bottlers and customers as needed
• Function as a resource for general information and consultant for other technical teams in the company
• Protect information provided in confidence from outside sources i.e., bottlers and other business partner to ensure this information is not disseminated to those not directly involved in situations
• Determine actions needed to satisfy a customer requirement
• Establish relationships and collaborate effectively with external individuals / parties, i.e., customers, bottlers, consumers, communities, government agencies, vendors, suppliers, etc.

in order to create opportunities for the company to meet financial goals

• Build and maintain relationships with peers and others to exchange feedback on product and service issues, identify and / or solve problems, assess needs, and / or achieve business results
• Develop an understanding of the customer needs and expectations for specific location(s)
• Work with cross-functional teams to meet short and long-term business objectives using established procedures and developing new approaches
• Lead capital construction and / or high-profile projects that involve cross-functional teams
• Analyze and interpret technical information to provide governance and stewardship as wells as to identify new approaches to address barriers
• Manage Periodic Automatic Replacement (PAR) and also Material Safety Data Sheets (MSDS) and transportation when interacting with field on customs issues
• Manage complex regulatory issues affecting products, ingredients, packages or claims
• Interact with government officials to represent the company or soft drink industry while explaining complex scientific data, reports or issues
• Other projects or duties as assigned

Qualifications

Required Skills and Experience :

• Bachelor’s degree with 6 plus years of related work experience in a manufacturing environment and 3 plus years of people leadership experience or HS Diploma / GED with 9 plus years of related work experience in a manufacturing environment and 4 plus years of people leadership experience
• Experience in food chemistry, engineering, toxicology and microbiology in making decisions about the safety of ingredients, beverages, manufacturing techniques, packaging and storage conditions
• Strong knowledge of packaging materials, i.e., can and end, closure, glass bottle, plastic bottles, and thermally processed and sensitive beverages
• Strong knowledge of material design, functionality, performance standards, specifications and test procedures
• Strong knowledge of manufacturing, filling, supply chain and costing
• Ability to apply scientific and technical knowledge to deliver new products or product improvements
• Strong knowledge of consumer behavior, product positioning and branding, and marketplace dynamics
• Excellent project management skills
• Experience working with cross-functional teams
• Excellent Regulatory Affairs skills
• Expert Regulatory Knowledge i.e., regulatory issues and political landscape affecting food and beverages globally
• Ability to anticipate issues or concerns of interest to public health officials in order to respond to those concerns
• Experience advocating a position in a non-adversarial manner
• Proficient with Microsoft Office, i.e., Excel, PowerPoint, Word, etc.
• Travel up to 10%
• This position must pass a post-offer background and drug test

Preferred Skills and Experience :

• Master’s degree
• ISO 9001 and 22001 lead auditor
• HACCP, PCQ1 and GMP compliance
22 days ago