Galderma
Global Product Development Quality Specialist
Galderma, Carlsbad, California, United States, 92002
Overview
Location: Carlsbad, CA Job Title:
Product Development Quality Specialist The Product Development Quality Specialist - Consumer Products role is part of the Global Product Development Quality team. You will ensure that Galderma products meet company quality standards and comply with relevant government regulations based on product classification (cGMP, GDP, ISO, ICH or other applicable regulations and guidance) with a strong focus on Consumer Business. The development of new cosmetics, OTC and drugs requires proactive leadership in interdisciplinary project teams. Responsibilities
Lead the product innovation projects in Quality Actively participate in and represent Quality in appropriate product development team meetings Review and approve product and packaging component specifications in collaboration with R&D and MS&T teams Review and approve stability data and reports and approve shelf-life statements for NPD projects Review and approve analytical method development and validation protocols and reports Prepare impurities and degradation products risk assessments for OTC products Collaborate with R&D, MS&T and Operations to ensure product design and development contributes to process improvement and target OEE at the production site Ensure adherence to applicable regulatory GMP requirements and Galderma internal requirements throughout product development processes Lead Quality Risk Management for projects and apply Lean and Lean Six Sigma to minimize compliance and supply chain risks Lead resolution of quality issues identified in projects Initiate, perform and document quality investigations, deviations and CAPAs related to product development in the Galderma QMS Initiate, assess and manage Change Controls in the Galderma QMS and coordinate timely implementation with stakeholders Oversee stability studies of products during development Promote improvement programs and alignments for CDMO(s) involved in projects Share knowledge and train colleagues on relevant regulations Ensure customer satisfaction and regulatory compliance in all markets Manage and/or support quality aspects for products through the full lifecycle, from development to commercialization Support transition of development deliverables to Operations & Commercial Quality and assist with post-transition quality issues QMS and Management of Product Development Quality Documents
Design and coordinate the implementation of the company Quality Management System and promote continuous improvement Evaluate QMS robustness and contribute to quality risk assessment Ensure product development documentation complies with GDPs and is maintained in the Galderma Document Management System Participate in creation and revision of Galderma procedures and work instructions related to product development Support as the main Quality contact in continuous improvement projects related to the QMS and Document Management System Promote GMP and GMP-compliant ways of working; support evolving regulatory requirements during product development and post-transition Provide GMP and GDP training as needed Requirements
Minimum 5 years of experience in a Quality role in pharmaceutical and/or cosmetic industry Experience with Cosmetics GMPs and development is required Strong knowledge of ICH quality guidelines Demonstrated knowledge of analytical chemistry method development and validation Experience in cosmetic production and process improvements is a strong asset Experience in China CSAR requirements is a strong asset Knowledge of Project Management, Lean and Lean Six Sigma, and Quality Risk Management is a strong asset Demonstrated knowledge and execution in a Quality Management System (QMS) Ability to manage external partners Ability to work in a matrix organization (affiliates, global, vendors and partners) Ability to work independently with minimal supervision Clear and professional written and verbal communication Ability to interpret and apply quality standards Flexibility and agility in problem solving to meet business objectives Education/Training
Bachelor’s degree in Life Science or a related field Knowledge of Regulations
Strong knowledge of Cosmetic Regulation (ISO 22716) Strong knowledge of Pharmaceutical GMP and ICH guidelines (USFDA, Health Canada, Eudralex, TGA, etc.) GDP regulatory requirements Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Consumer Services
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Location: Carlsbad, CA Job Title:
Product Development Quality Specialist The Product Development Quality Specialist - Consumer Products role is part of the Global Product Development Quality team. You will ensure that Galderma products meet company quality standards and comply with relevant government regulations based on product classification (cGMP, GDP, ISO, ICH or other applicable regulations and guidance) with a strong focus on Consumer Business. The development of new cosmetics, OTC and drugs requires proactive leadership in interdisciplinary project teams. Responsibilities
Lead the product innovation projects in Quality Actively participate in and represent Quality in appropriate product development team meetings Review and approve product and packaging component specifications in collaboration with R&D and MS&T teams Review and approve stability data and reports and approve shelf-life statements for NPD projects Review and approve analytical method development and validation protocols and reports Prepare impurities and degradation products risk assessments for OTC products Collaborate with R&D, MS&T and Operations to ensure product design and development contributes to process improvement and target OEE at the production site Ensure adherence to applicable regulatory GMP requirements and Galderma internal requirements throughout product development processes Lead Quality Risk Management for projects and apply Lean and Lean Six Sigma to minimize compliance and supply chain risks Lead resolution of quality issues identified in projects Initiate, perform and document quality investigations, deviations and CAPAs related to product development in the Galderma QMS Initiate, assess and manage Change Controls in the Galderma QMS and coordinate timely implementation with stakeholders Oversee stability studies of products during development Promote improvement programs and alignments for CDMO(s) involved in projects Share knowledge and train colleagues on relevant regulations Ensure customer satisfaction and regulatory compliance in all markets Manage and/or support quality aspects for products through the full lifecycle, from development to commercialization Support transition of development deliverables to Operations & Commercial Quality and assist with post-transition quality issues QMS and Management of Product Development Quality Documents
Design and coordinate the implementation of the company Quality Management System and promote continuous improvement Evaluate QMS robustness and contribute to quality risk assessment Ensure product development documentation complies with GDPs and is maintained in the Galderma Document Management System Participate in creation and revision of Galderma procedures and work instructions related to product development Support as the main Quality contact in continuous improvement projects related to the QMS and Document Management System Promote GMP and GMP-compliant ways of working; support evolving regulatory requirements during product development and post-transition Provide GMP and GDP training as needed Requirements
Minimum 5 years of experience in a Quality role in pharmaceutical and/or cosmetic industry Experience with Cosmetics GMPs and development is required Strong knowledge of ICH quality guidelines Demonstrated knowledge of analytical chemistry method development and validation Experience in cosmetic production and process improvements is a strong asset Experience in China CSAR requirements is a strong asset Knowledge of Project Management, Lean and Lean Six Sigma, and Quality Risk Management is a strong asset Demonstrated knowledge and execution in a Quality Management System (QMS) Ability to manage external partners Ability to work in a matrix organization (affiliates, global, vendors and partners) Ability to work independently with minimal supervision Clear and professional written and verbal communication Ability to interpret and apply quality standards Flexibility and agility in problem solving to meet business objectives Education/Training
Bachelor’s degree in Life Science or a related field Knowledge of Regulations
Strong knowledge of Cosmetic Regulation (ISO 22716) Strong knowledge of Pharmaceutical GMP and ICH guidelines (USFDA, Health Canada, Eudralex, TGA, etc.) GDP regulatory requirements Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Consumer Services
#J-18808-Ljbffr