Job Summary:
The Quality Manager for Switzerland will be responsible for managing and ensuring the quality compliance of distributor agreements worldwide and inter-group agreements from the Swiss entity. The role also includes overseeing the quality requirements for domestic Swiss sales and supporting the workload for the Swiss Trading Partner. The Quality Manager will work closely with distributors, internal stakeholders, and regulatory authorities to ensure that all processes comply with both Swiss and international quality and regulatory standards.
Key Responsibilities:
1. Distributor and Inter-group Agreements:
Manage the quality aspects of distributor agreements globally, ensuring compliance with quality standards and regulatory requirements. Oversee inter-group agreements from the Swiss entity, ensuring that all quality and regulatory conditions are met. Maintain strong relationships with global distributors and ensure clear communication on quality expectations and performance monitoring. Perform audits of third-party distributors to verify adherence to the company’s quality standards.
2. Quality Support for Swiss Trading Partner:
Provide quality management support to the Swiss Trading Partner, including ensuring compliance with Swiss regulations and Good Distribution Practices (GDP). Ensure that all required documentation and certifications are in place for smooth trading operations. Serve as a key point of contact for any quality-related issues with the Swiss Trading Partner and coordinate solutions in a timely manner.
3. Domestic Sales – Switzerland:
Oversee the quality requirements for domestic sales in Switzerland, ensuring compliance with local regulatory bodies and maintaining the highest quality standards for all products. Coordinate with sales and marketing teams to ensure all products in the Swiss market meet quality standards before distribution. Handle quality complaints, investigations, and implement corrective actions for the Swiss market.
4. Regulatory Compliance:
Ensure compliance with Swiss and international regulatory standards, including Swissmedic, GDP, GMP, ISO standards, and other relevant requirements. Manage the submission of product registrations, certifications, and compliance documentation for Switzerland and global distribution partners. Stay up to date with evolving regulatory requirements and implement changes to the quality management systems as needed.
5. Audits and Inspections:
Lead preparation for and execution of audits and inspections by regulatory authorities and third-party certifiers. Develop and implement corrective and preventive actions (CAPA) for non-conformities found during internal and external audits.
6. Supplier and Vendor Management:
Manage quality compliance for all suppliers and vendors supporting the Swiss and global distribution operations. Ensure supplier qualification, conduct audits, and monitor supplier performance against agreed quality metrics.
7. Quality Management Systems (QMS):
Maintain and enhance the Quality Management System (QMS) to ensure it meets local Swiss and international standards. Develop and implement Standard Operating Procedures (SOPs) related to global distribution and domestic sales operations. Ensure proper documentation, including product batch records, CAPA reports, and quality agreements.
8. Risk Management:
Implement risk management strategies to identify and mitigate potential quality risks associated with global distribution and domestic sales. Lead product quality investigations, root cause analysis, and resolution of quality issues in collaboration with cross-functional teams.
9. Training and Continuous Improvement:
Provide training on quality standards, SOPs, and regulatory requirements to internal teams and distributors. Lead quality improvement initiatives to enhance efficiency, reduce risks, and improve compliance across global and Swiss operations.
Qualifications:
- Education: Bachelor’s or master’s degree in Life Sciences, Pharmacy, or related field.
- Experience: Minimum 5-7 years of experience in quality management within the consumer healthcare, pharmaceutical, or medical device industries. With specific experience of Swiss Medicines licences and the regulator.