CHC Affiliate SK – Country Quality Head/ Responsible Person

About us

At Sanofi Consumer Healthcare (CHC), our ambition is to be the best Consumer Healthcare business in the world. We are driven to serve healthier, fuller lives for the people by offering a wide range of solutions across four main areas: Cough & Cold, Allergy, Pain Care, Nutritional Health and Digestive Health.

About growing with us

The purpose of this position is to:

• Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements
• Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities
• As Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate market place in compliance with Act 362/2011 Coll., on Pharmaceuticals and medical devices as amended and Act 331/2005 Coll., on Narcotic precursors as amended
• Focal point of contact in front of the Competent Authorities for any CHC product quality/technical, GMP and GDP-related matter

Your Key Contributions & Activities will be:

As CHC Affiliate Country Quality Head:

• Define, implement, manage and control the CHC Affiliate Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements
• Organize within the CHC Affiliate a consistent management of Quality Documents related to GxP and health-regulated activities
• Implement a screening process of released CHC Global Quality Documents and of local regulations to capture the requirements that must be transcribed into CHC Affiliate Quality Documents
• Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and related training modules in their respective domains
• Manage CHC Affiliate regulatory inspections related to GxP processes owned by the CHC Affiliate Country Quality Head and provide support to and coordination to other GxP Affiliate Functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed)
• Define and implement process to manage deviations and CAPAs related to GxP and health-regulated activities including those related to audits and inspections findings across the country in a consistent manner
• Ensure that an appropriate process is in place regarding product protection (counterfeits)

As CHC Affiliate GDP/Wholesale Distribution Responsible Person:

Ensure that all the Wholesale distribution activities covered by the corresponding Wholesale Distribution License (WDL) are operated by the CHC Affiliate in full compliance with GDP requirements.

As CHC Affiliate Responsible Person in accordance with Act 331/2005 Coll.:

Manage the records and documentation prescribed by this Act and fulfill the reporting obligations prescribed by this Act.

About you

Required skills and experience:

• Practical experience in Quality System Management in Health regulated industry
• Education: Master´s degree in Pharmacy
• Knowledge & experience in Medical, Clinical or in pharmacovigilance domain
• Fluent English
• Practical GDP experience
• Meet local regulations for nomination of Responsible Person
• Advanced skills in: GxP (namely GMP, GDP) and health regulated regulations, Quality Systems/Affiliate Quality management (commercial organization), Continuous improvement management, Quality risk analysis/ Quality risk management, Act for change with agility
• Communication skills (oral & written, English)
• Internal and external networking capability
• Project management skills
• Leadership and assertiveness skills
• Negotiation and influential skills

This is our Sanofi. Discover yours.

http://www.lmcg2.com/pd/1510634665?rps=183&source=10&exportID=0