Job Description

QUALITY ASSURANCE MANAGER

Strive Pharmaceuticals is a packager and manufacturer of solid dose and topical over-the-counter medications. The company follows strict cGMP guidelines and is audited by FDA.

Your talents, expertise, ideas and passion are essential to our mission; to help develop, manufacture and supply products that help people live better, healthier lives.

POSITION OVERVIEW JOB DESCRIPTION

The QA manager is responsible for supporting Quality Systems, including hosting client/regulatory inspections, conducting for cause and internal audits as assigned, coordinating audit logistic planning/prep, inspection readiness training, drafting audit reports and responses, conducting inspection readiness/compliance training, investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate cGMP manufacture of consumer over-the-counter medications.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Responsible for leading and directing the overall activities of the plant Quality Operations.
• Providing leadership and direction for Quality Assurance, Quality Services (Analytical Development, Compliance, Stability), Quality Systems, Compliance, and Quality Control functions
• Review and provide comments and approval on all OTC product label/labeling to meet FDA quality and regulatory compliance
• compliance with USFDA quality and regulatory requirements.
• Provide review, comments, and approval of all product claims for technical accuracy and regulatory compliance
• Prepare, maintain product files and submit product listing registration and establishment of documents or all OTC products
• Acts as the Management Representative for the Quality Management System and is responsible for its effectiveness
• Responsible for developing the quality unit and managing the activities to establish, maintain and enforce a high level of excellence with regards to cGMP compliance
• Ensures key quality systems are developed and implemented in accordance with regulatory requirements
• Ensures development and oversight of programs with broad impact on site and US quality as well as metrics to assure the maintenance of such programs
• Provides periodic quality status reports
• Conduct internal audits, audit compliance with legal and other requirements, and monitor the results of the process performance on a regular basis
• Provide the best regulatory strategy in compliance with local and international regulatory requirements for OTC products and new product developments
• Create regulatory data for all ingredients and raw materials based on Federal and State Regulations (FDA) and internal guidelines/restrictions.
• Review raw material compositions and conformity of ingredients depending on product type and usage
• Prepare, submit and maintain records of registration in pertaining to California's Prop 64, SB 484
• Daily responsibilities as assigned by management.

THE CANDIDATE

• Minimum of a B.S. in a Life Sciences discipline • +5-7 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry and +2 years’ experience in Quality / Compliance function

• ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable

• Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems Strive Pharma’s standard leadership competencies that are used to interview and for Performance & Development

• Leads with Integrity and Respect

• Attention to details and error-proofing

• Delivers Results

• Demonstrates Business Acumen

• Fosters Collaboration and Teamwork

• Champions Change

• Engages and Inspires

• Coaches and Develops Position Benefits

• Potential for career growth within an expanding saving and life-enhancing products to patients around the world.

Strive is an exciting and growing international company where employees work directly with pharma and consumer retailers. Join us today!