Country Quality Head CHC Korea
Seoul, South Korea Permanent Date posted 03/06/2024Job title: Country Quality Head CHC Korea
- Location: South Korea
- Hybrid
- Job type: Permanent, Full time
About the job
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
Our Team:
The CHC Affiliate Quality team at Sanofi is dedicated to ensuring the highest standards of product quality and regulatory compliance. We are a diverse and dynamic group, committed to fostering a culture of excellence and continuous improvement. Our mission is to support Sanofi's commitment to delivering safe and effective healthcare solutions, working collaboratively across functions to achieve our goals and drive success in the fast-moving consumer health market.
Main Responsibilities
- Define, implement, manage, and control the CHC Affiliate Quality system across the CHC commercial office in compliance with CHC Global Quality Policy, standards, and local regulatory requirements.
- Organize consistent management of Quality Documents related to GxP and health-regulated activities within the CHC Affiliate.
- Implement a screening process for released CHC Global Quality Documents and local regulations to capture requirements for CHC Affiliate Quality Documents.
- Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and training modules.
- Manage CHC Affiliate regulatory inspections related to GxP processes and support other GxP Affiliate Functions in country regulatory inspections.
- Ensure appropriate training on quality basics/matters for CHC Affiliate personnel.
- Carry out an annual CHC Affiliate Country Quality Review and monitor the progress of Affiliate Quality program actions.
- Implement a process to manage deviations & CAPAs related to all GxP and health-regulated activities.
- Set up a process to manage changes impacting GxP or health-regulated processes or operations.
- Ensure valid and signed Quality agreements are in place for all GDP/GMP activities.
- Manage quality risks and escalate quality events within the CHC Affiliate according to defined processes and standards.
- Maintain up-to-date administrative records and provide guidance to ensure compliance.
- Manage the quality of CHC products, perform trend analysis, and lead product batch recalls.
- Ensure quality oversight on management of CHC product distribution issues including temperature excursions.
- Perform local Market Batch Release/Disposition and oversee local distributors as required.
- Manage notifications from and to local Health Authorities for CHC product-related quality events.
- Foster quality culture across the CHC Affiliate, interact with Senior Leaders, and manage the CHC Affiliate Quality budget.
About You
Experience:
- More than 6 years’ practical quality work experience in the pharmaceutical industry and in Quality System Management in Health regulated industry.
- Must have knowledge in Quality and Quality Regulatory compliance.
- Strong autonomy in work, self-confident, strong work ethic, pragmatic and result-oriented, resilient, and able to work under pressure.
- Project management skills and cross-functional competencies.
- Advanced level of reading, spoken, and written English.
Soft Skills:
- Act for change with agility.
- Commit to customers.
- Cooperate transversely.
- Business Partnering.
- Strategic planning skills.
Technical Skills:
- Quality System Management.
- GxP regulatory knowledge.
- Project management.
Education: MUST be KR Registered Pharmacist.
Languages: Fluent Korean and English (reading, writing, and speaking skills).
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