Job Title: ESO Quality Assurance Manager
Location: Shanghai, China
Job Description
Ensure 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.
He/she will rely on regulatory, industry and technical expertise to:
* Monitor, guide and promote Quality at ESO
* Support Galderma Markets/distributors on products provided by ESO.
Initiates continuous improvements actions and develop business excellence approach across ESOs/API suppliers
The Job holder is responsible for the GMP/GDP activities in his scope related to Cosmetics/ Medicinal products according to but not limited to the following requirements:
* China NMPA New Cosmetics Requirements (CSAR) and China Safety and technical Standards for Cosmetics (STSC) and relevant GB
* ISO 22716 Cosmetics Guidelines on Good Manufacturing Practices
* The Cosmetic Regulation (1223/2009)
* Local GMP and regulatory requirements
* EU- GMP Guideline Chapter 4
* Swiss MLPO Chapter 2, Section 1-3
* EU GDP Guideline according 2013/C 343/01
The Job holder ensures that his team works in compliance with these above-mentioned regulation
Scope
Galderma's ESO Oversight
Support to the other Galderma divisions and Market on their ESO Quality related topics.
Primary QA Contact for ESO
Technical support to comply with local regulatory requirements
Primary lead for Technical Quality Agreements approval and renewal
QA contact for communication of QA issues to the ESO
QA support for audits, investigations, trends, complaints, investigations, corrective and preventive actions (CAPA), validation support, and product release issues as needed
QA support of projects including but not limited to new product introduction, product/industrial transfers (production and analytical) for routine product, life-cycle management changes/geoexpansions
Provide KPI & perform Quality Review with ESO
Quality Management review of ESO including in the Portfolio.
Coordination of activities with various Galderma stakeholders such as Supplier Relationship Team, Supply Chain, Procurement, Legal, etc. to manage the relationship, manage crisis and supply issues, etc.
Duties and responsibilities
The incumbent will define performance & regulatory compliance related goals, objectives and KPIs for ESO
He/she will provide leadership to co-ordinate the operational quality management of ESO
He/she will promote improvement programs and alignments in all related ESO.
He/she will be actively involved in the resolution of critical/major quality issues (leading to supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations
This position will accompany ESO to favor continuous improvement program and preventive actions over corrective actions
He/she will provide support in the interpretation and application of regulatory guidelines to ensure that ESO/API Suppliers adhere to regulatory requirements and are consistent with industry standards
He/she will provide expert interpretation and application of regulatory guidelines to ensure that ESO/API Suppliers adhere to regulatory requirements and are consistent with industry standards
He/she will notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance.
The Job holder is responsible for the GMP/GDP activities in his scope related to medicinal products according following requirements:
China NMPA New Cosmetics Requirements (CSAR) and China Safety and technical Standards for Cosmetics (STSC) and relevant GB
ISO 22716 Cosmetics Guidelines on Good Manufacturing Practices
The Cosmetic Regulation (1223/2009)
Local GMP and regulatory requirements
EU- GMP Guideline Chapter 4
Swiss MLPO Chapter 2, Section 1-3
EU GDP Guideline according 2013/C 343/01
The Job holder ensures that his team works in compliance with these above mentioned regulation
Knowledge of different regulations:
SO 22716 Cosmetics Guidelines on Good Manufacturing Practices
The Cosmetic Regulation (1223/2009)
Local GMP and regulatory requirements
GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories),
GDP regulatory requirements
Medical Device applicable regulations (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, …).
ESO/API Suppliers
ESO SRT
Global ESO Functional Lead
Global & Local Supply Chain
Global & Local Procurement
Global & Local Regulatory Affairs
GBU
Skills & Qualifications
Pharmacist or Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline; advanced degree is preferred.
Six Sigma / Lean Manufacturing certification is a serious plus.
At least 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry.
English and Chinese fluent written and oral, other spoken languages are an asset in building connections with the functions / regions / countries.
MS Office (Word, Excel, Power Point).
eDocument Management, PATH Training, Trackwise (Deviations, Inquiries & Complaints, CAPA's, Changes, Audits and Action plan)
a sound knowledge of the applicable regulations for drugs, cosmetics, medical devices.
a demonstrated knowledge and execution of Quality Operations
Capacity to negotiate and manage external partners
Ability to work in matrix organization (affiliates, global, ESO)
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 are expected
Ability to move and adapt in a fast-changing business environment.
Knowledgeable in several areas of the global pharmaceutical/consumer industry, including the interpretation and practical application of applicable regulations.
Able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely affect activities across several departments.
What we offer in return
At Galderma, you have the opportunity to gain new and challenging work experience and create an unparalleled, direct impact. We offer careers in innovation and accountability, empowered by diverse, collaborative colleagues across functions and geographies who share their passion to advance dermatology for every skin story.
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.