Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Product Development Quality Specialist
Location: Carlsbad, CA
The Product Development Quality Specialist – Consumer Products Role is part of the Global Product Development Quality team. As the Product Development Quality Specialist, you will ensure that Galderma products meet the company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH or any relevant regulations and guidance with a strong focus on Consumer Business. The development of new cosmetics, OTC and drugs require your proactive leadership in the interdisciplinary project teams.
Roles and Responsibilities:
Product Development Projects:
- Lead the product innovation projects in Quality
- Actively participate and represent Quality in the appropriate product development team meetings
- Review and approve product / packaging component specifications in close 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
- Responsible for preparation of impurities and degradation products risk assessments for OTC products
- Responsible to work with R&D, MS&T and Operations teams to ensure design and development of products contribute to improve processes and achieve target OEE in production site.
- Responsible to ensure adherence to the relevant applicable regulatory GMP requirements as well as Galderma’s internal requirements throughout all the processes in product development projects
- Lead the Quality Risk Management for his/her projects and use the Lean and Lean Six Sigma methods to minimize Compliance and Supply Chain Risks
- Lead the resolution of quality issues identified in projects
- Responsible to initiate, perform and document quality investigations, deviations and CAPA’s related to product development in Galderma QMS
- Initiate, assess and handle Change Controls in Galderma QMS and work with all stakeholders for timely implementation of the changes
- Responsible for stability studies of products during development projects
- Promote improvement programs and alignments for C(D)MO(s) involved in the projects
- Share knowledge and train colleagues on relevant regulations
- Ensure customers satisfaction as well as regulatory compliance in all markets
- Manage and/or support all quality aspects for products through its entire lifecycle, from development to commercialization
- Support transition of product development deliverables to the relevant stakeholders within Operations & Commercial Quality and provide support on quality issue(s) linked to product development arising post-transition
QMS and Management of Product Development Quality Documents:
- Design and coordinate the implementation of the company Quality Management System and promoting its continuous improvement
- Evaluate the robustness of the QMS and weigh in on quality risks
- Ensure all documentation related to product development are done properly according to GDP’s and maintained in Galderma Document Management System
- Participate in creation and revision of Galderma procedures and work instructions related to product development
- Actively support as the main Quality person in continuous improvement projects related to the company QMS and Document Management System
- Work with all stakeholders and promote GMP and the GMP compliant way of working, including support the implementation of evolving regulatory requirements during product development phase and/or post-transition
- Perform training on GMPs and GDPs 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 a must.
- Strong knowledge of ICH Quality guidelines
- Demonstrated knowledge in 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 are strong assets.
- Demonstrated knowledge and execution in Quality Management System (QMS)
- Ability to manage external partners
- Possess ability to work in matrix organization (affiliates, global, vendors and partners)
- Ability to work independently with minimal supervision
- Communicate clearly and professionally in both writing and verbally
- Ability to interpret and relate quality standards for implementation
- Flexibility and agility in problem solving, providing direction to meet business objectives as expected
- Fluent in English (written & spoken)
Education/Training:
- A Bachelor’s degree in Life Science or in a relevant subject
Knowledge of different regulations:
- Strong knowledge of Cosmetic Regulation (ISO 22716) is a must
- Strong knowledge of Pharmaceutical GMP and ICH guidelines (USFDA, Health Canada, Eudralex, TGA, etc.)
- GDP regulatory requirements
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