Quality Manager

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.

Location: Seoul Head Office
Reporting to : Head of Quality JPAC & Head of RA Korea

Job summary:
• Ensure that quality of the finished drug/cosmetic/medical device products that are imported and distributed by Galderma Korea is complied with both Korea pharmaceutical/cosmetic/medical device laws and the related regulations and Galderma Corporate Quality Policy (Quality policy and the relevant SOP) including GxP requirements.
• Manage Quality operations that are impact to quality of products in accordance with the related local regulations and Galderma Corporate Quality Policy.
Key duties and responsibilities:
• Product Compliance Management
- Manage the overall quality from receipt to release of all drug/cosmetic/medical device products.
- Manage that local QC test for all drug/cosmetic products are conducted before being released to the market including reference standard management and conduct the review the QC results that is compliant with testing specifications.
- Report and monitor monthly KPIs
- Conduct Q/PV Management Review based on KPI data and implement the actions for improvement.
- Manage the Standard Operating Procedures compliant to GxP regulations and Galderma Corporate Quality Policy.
- Manage the effective Change Control process, documentations and archiving of Quality data and records including Product master files and imported product management record to be compliant with local regulations and Galderma Corporate Standards.
- Plan and executes artwork modification activities including local redressing materials that are compliant with the local related regulation.
• Quality operation
- Manage external inspections, internal Audits, complaints and deviations according to the Galderma Corporate Standard and local written procedures and implement each CAPA timely.
- Manage the customer complaints including reporting to appropriate investigation sites, managing investigation process, ensuring that appropriate corrective actions are taken.
- Conduct trend analysis for customer complaints regularly and execute CAPA based on the results if necessary.
- Conducts regular vender audit of third parties to guarantee that warehousing/ distribution, transportation, local QC testing, printing redressing materials are in compliance with Galderma Corporate standards.
- Maintain valid Quality Agreements with third parties.

- Conduct the Quality training for GIP and GDP related activities by planning, supporting and performing training activities.
- Ensure that returned and defective products are managed and disposed in accordance with Galderma Corporate Standards.
- Manage external inspections, complaints and deviations
- Conduct Product Quality Review annually and execute necessary actions if needed.
- Communicate with Quality team regularly for any quality issues occurred in Korea including 1:1 meeting with Head of Quality JPAC.
• RA Support
- Conduct the review of GMP documents including analytical specification/methods for new registration/variation
- Support site inspections.
OTHERS:
Weekly/Monthly Report
Galderma Corporate Quality project

Experience/Competencies:

- Minimum 7-9 years’ work experience in pharmaceutical industry but at least 5 years of experience in quality

- Bachelor degree and/or above major in sciences related required and pharmacist preferred. - Strategic & positive mind set

- Leadership & followership - Good project management skills

- Good working relationship with internal and external bodies

- Fluency in both written and spoken English

- MS office (Word, PowerPoint and Excel)