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Director of Quality Assurance/ Quality Control jobs in United States
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Life Extension · 9 hours ago

Director of Quality Assurance/ Quality Control

Life Extension is a company focused on Quality Assurance and Quality Control in the nutritional supplement industry. The Director of Quality Assurance/Quality Control will oversee the entire Quality Unit and collaborate with various functional areas to ensure adherence to regulatory requirements and maintain quality systems.
Dietary SupplementsHealth CareHealth DiagnosticsMedical

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

Qualification

Quality AssuranceRegulatory ComplianceAuditing SkillsNutritional Supplement ManagementMicrosoft OfficeCQA CertificationCQE CertificationDelegationProblem-SolvingCommunication SkillsProject Management

Required

Bachelor's degree in science field
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
Strong problem-solving skills

Preferred

Advanced degree preferred (MS, PhD)
CQA or CQE certification preferred

Company

Life Extension

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Life Extension is a health solution expert that involving the use of dietary supplements and nutritional strategies.

Funding

Current Stage
Growth Stage

Leadership Team

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Andrew Swick
Chief Scientific Officer
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Rey Searles
Chief Marketing Officer
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Company data provided by crunchbase