Growing manufacturing company in rural New Mexico is looking for an experienced Quality Manager with excellent cGMP skills. You will join a team that strongly believes protecting the safety and quality of our products to be a core mission. This requires a person who is able to provide leadership and guidance in our manufacturing facility, ensuring compliance with our internal SOPs and current FDA regulations. You will make certain our products meet the highest standards for safety, quality and health and be responsible for the management of the day-to-day quality functions of our overall manufacturing services: preparing and completing action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements and implementing change.
Ensure compliance to applicable local, state, federal and international regulations, good manufacturing practices, good laboratory practices, and internal standards for materials, manufacturing and/or distributed finished products, packaging and labeling. Responsible for the development and implementation of all quality systems.
-Responsible for all material and product approvals, releases, and rejections.
-Responsible for quality control and quality assurance of materials and finished products.
-Primary contact during cGMP, Regulatory, and Customer audits.
-Identify and oversee consultants that perform specific quality (QA, QC, QA Systems) work for the company.
-Lead all investigations (complaints, non-conformities, supplier issues, audit findings, etc.); correspondences to regulatory audits; and registration of products and facility with agencies.
-Ensure compliance to all SOP's and other regulatory requirements (FDA, ISO, OSHA, and EPA).
-Responsible for periodic quality reviews and annual GMP Training.
-Responsible for formal drug stability program, process validation, calibration program, change management, coordination of employee training program.
-Responsible for supplier qualification program, contract laboratory and vendor audits; internal and external audits.
-Responsible for SOP's, approval of specifications, and Change Control program.
-Responsible for quality management system (QMS) in compliance with 21 CFR Part 210 and 211.
-Must be familiar with regulatory requirements for formula and product development pertaining to cosmetics and over-the-counter (OTC) drugs.
-Leads the manufacturing Quality organizations in implementing continuous improvement activities.
-Set quality goals and metrics
-Roll up site Quality Management Reviews to initiate and ensure continuous effort on quality system improvement and provide feedback for on-going improvements. Chair the Quarterly Quality Council Meeting.
Education: Bachelor's Degree in science related field (Chemistry, Biology, or Microbiology) is required. Advanced scientific degree is preferred.
Experience: 6 -8+ years of Quality Assurance experience in pharmaceutical, nutraceutical, food and beverage, cosmetics, or federally regulated manufacturing organization.
Skills and Competencies:
• Demonstrated track record and experience leading professionals in a complex environment.
• Direct working knowledge of the business environment outside of the quality organization (manufacturing, product/process development, customer service, etc.)
• Working knowledge of the business environment inside a quality organization, across various roles (quality operations, QC, Quality Systems, pre-production quality assurance, validation, and regulatory).
• Demonstrated knowledge of applicable regulations within the US (FDA and ISO).
• Excellent leadership and communication skills, with an open, collaborative, interactive leadership style.
• Demonstrated strategic thinking capabilities, ability to help define a vision for the future.
• Ability to translate strategy to execution and drive the organization forward in executing and delivering results.
• Results-driven leader who commits to stretch goals and deliver results.
• Balanced decision-maker
• Excellent collaborative leadership style and coaching skills with ability to build and nurture strong, positive relationships with business leadership and cross functional partners.
• In-depth experience in dealing with regulatory inspections and inspection requirements
• Demonstrated leadership in bringing products through launch.
• Proven ability to drive proactive quality and ability to bring quality solutions to issues at a senior management level.
• Knowledge as well as application and data interpretation skills with respect to QA/QC, regulatory compliance, lab operations, testing guidelines and processes, stability study, related substances, etc.
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