Position Title: CHC Country Quality Manager

Location: Błonie warehouse/ Warsaw office

About the job

The CHC Country Quality Manager supports the implementation and maintenance of the CHC Polish Affiliate Quality System, ensuring compliance with GxP regulatory requirements, CHC Global Quality standards, and national EU legislation.

This role includes acting as back-up Good Distribution Practices Responsible Person according to Business Contingency Plans.

Key responsibilities:

• Support design, implement and improve Quality Management System & Quality Processes, ensure their respective implementation in the electronic Document Management System.

• Support managing authorized activities, ensuring accuracy and quality of records.

• Ensuring adherence to national law requirements.

• Develop, roll-out training activities and oversee training effectiveness.

• Contribute to the qualification and approving of suppliers, customers and subcontracted activities impacting GxP

• Coordinating promptly recall operations for CHC products.

• Support in the identification and mitigation of Quality risks and define action plans in areas as Quality Events, change management, audits and (self-)inspections.

• Conducting regular self-inspections and implementing corrective measures.

• Support  quality  audits and inspections at the local level.

• Handling customer complaints effectively.

• Ensure Product Quality is maintained through the management of in-market Product Quality Complaints and the effective management of Quality incidents.

• Release products for the sale at the local level.

• Oversee the storage conditions of medicinal products 

• Evaluate returned products in the redistribution process

• Contribute to continuous improvement efforts through data analysis and trending.

• Manage activities related to the Falsified Medicine Directive.

Scope and Role Impact:

• Cross-functional management within the CHC PL Affiliate.

• Key role in ensuring consistent application of Quality requirements.

Required Skills and Experience:

• Educational Qualifications: Candidates must possess  of the legal diploma of pharmacist

• Experience: Candidates should have significant experience in the Good Distribution Practice (GDP) domain within an affiliate setting and you must be able to demonstrate, that you have a minimum of 2 years’ experience in performing the functions of a Responsible Person/  Responsible Person back-up on a WDA(H).

• Knowledge:

  • Understanding of GxP, quality risk analysis and management, regulatory requirements.

  • Familiarity with EU/PL Pharmaceutical Law & Good Distribution Practices.

• Languages:

  • Proficiency in Polish and English.

• Technical/Professional:

  • Experience in Quality Systems, Continuous Improvement and Life-cycle Management.

• Soft Skills:

  • Excellent communication and diplomacy skills.

  • Good sense of organization, planning, priority setting and initiative.

  • Ability to work in a high paced and constantly changing environment.

  • Commit to customers.

  • Hands-on experience with MS Excel. Experience with other electronic platforms such as Veeva Vault, SAP is a plus

What we offer at Sanofi:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

• Access to internal recruitment and development libraries - you can create your own career path within Sanofi; your professional development will be supported purposefully

• Flexible home office policy, with a possibility to work up to 50% of time from home, where you can easily schedule your office days

• An attractive package of benefits, including company car

• Employee Assistance Program (mental health support, legal and financial consulting)

• Gender neutral paid parental leave

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability o