Director of Quality Assurance/ Quality Control

General Description: This position is significantly involved in Quality Assurance/Quality Control and regulatory issues at a hands-on level. This includes oversight of the entire Quality Unit, effectively collaborating with different functional areas (Purchasing, Product Development) to provide QA/QC expertise during various steps of the product launch process (from product conception to receipt of the product in inventory through product distribution). Includes oversight of all quality activities at the Northeast and Las Vegas Fulfillment Centers.

Core Duties and Responsibilities:

• Communicates with raw material suppliers, contract manufacturers and third-party laboratories to ensure that all service providers adhere to all relevant Life Extension and regulatory requirements.
• Always Maintains all Corporate and Fulfillment Center Quality Systems in a state of audit readiness.
• Ensures company (and contract manufacturers) adhere to all requirements of 21CFR111 and other applicable regulations.
• Designs, authors, reviews and approves SOP’s, Deviations, Investigations, Protocols and other technical documents for GMP related processes and ensures adherence.
• Reviews and approves all raw ingredients and finished product specifications.
• Tracks and trends customer complaints, product returns and other key quality metrics to drive Continuous Improvement initiatives within Life Extension and its contract manufacturers.
• Leads Customer Complaint and QC Investigation programs to ensure root cause and corrective actions (CAPA plans) are implemented accordingly.
• Directs all Supplier Management activities, including qualifications of raw materials, contract manufacturers, co-packers and contract laboratories.
• Provide direct oversight of all quality related activities at the Northeast and Las Vegas Fulfillment Centers.
• Directs all product testing activities, including raw material qualification, stability, finished product, IFOS, Consumer Lab and Amazon testing.
• Directs internal & external audit programs, including FDA and NSF inspections.
• Provides final review and regulatory oversight of all Life Extension labels.
• Provides Quality support for the Global Regulatory team in developing products for international markets.
• Acts as primary backup for product disposition decisions in the absence of the VP of Quality.
• Leads and develops direct reports.
• Assist in preparing and managing departmental budget.
• Travel up to 40% is required.
• Regular onsite attendance (when not on business travel) is an essential function of this position.
• Additional duties as needed.

Position Requirements:

• Bachelor’s degree in science field; Advanced degree preferred (MS, PhD)
• 10+ years of progressive nutritional supplement management experience
• Strong auditing skills required
• Excellent communication skills
• Ability to prioritize work, manage projects and delegate
• Advanced knowledge of Microsoft Office
• CQA or CQE certification preferred
• Strong problem-solving skills