Requirements: English
Company: J Safra Sarasin
Region: Collonge-Bellerive , Geneva
- To lead and drive the Quality oversight in assigned EMEA Cluster
- by serving as the primary liaison between Santen pharmaceutical Manufacturing and Distribution operations and the commercial affiliates in the assigned EMEA Cluster
- To ensure that all products distributed do meet the companys quality standards and regulatory requirements, safeguarding patient safety and product integrity.
- To act as Subject Matter Expert on (international) pharma legislation to the organization.
- Develop and maintain quality awareness in the organization and follow pharma legislation developments closely and make available to the organization.
- To fulfill the deputy RP(RT) / PRRC function for Santen SA (Switzerland) by working closely with the RP and the Distribution & Country Quality team to oversee the distribution activities, ensuring that pharmaceutical products are stored, transported, and handled in accordance with all local regulatory requirements and company standards.
- EMEA Cluster for this role is defined as : Distributor Markets. The Distributor Markets are defined as markets where local distributors are buying and owning products from Santen. In these countries there is no Santen Quality function present. These countries are primarily located in the ME (Middle East), North Africa, Balkan region, and Eastern Europe region).
Key Responsibilities & Accountabilities
- Regulatory Compliance and Oversight :
Support the RP / RT and PRRC in ensuring compliance with Swiss GDP regulations as per Swissmedic guidelines.
- Act as the designated deputy in the absence of the RP / RT and PRRC, maintaining full responsibility for GDP compliance during this period.
- Assist in the development, implementation, and maintenance of the Santen SA QMS to align with GDP requirements.
- Work closely with the RP / RT, Quality team, and supply chain partners to align GDP activities with overall business objectives.
- Liaise with Swissmedic and other regulatory authorities as needed to ensure a clear understanding of compliance expectations.
- Quality Leadership and Oversight :
Act as the primary quality contact between Santen and local distributors in assigned markets.
- Provide expert guidance on quality management processes to local distributors to ensure adherence to Good Distribution Practices (GDP), regulatory requirements, and company policies.
- There are no direct reports in this position.
Develop, implement, and maintain quality agreements / distribution agreements with local distributors, clearly outlining roles, responsibilities, and expectations.
- Monitor compliance of distributors with company standards and local regulatory requirements through audits, risk assessments, and performance reviews.
- Issue Resolution and Risk Management :
Investigate and resolve quality-related issues, including deviations, product complaints, and recalls, ensuring effective corrective and preventive actions (CAPAs) are implemented.
- Assess and mitigate risks associated with distribution channels to prevent product quality incidents.
- Training and Capacity Building :
Provide training to local distributor teams on GDP, quality systems, and regulatory requirements to build a culture of quality.
- Develop and implement quality management processes tailored to distributor operations.
- Collaboration and Stakeholder Engagement :
Collaborate with internal stakeholders, including manufacturing, regulatory affairs, and supply chain teams, to align quality objectives across the distributor markets.
- Foster strong relationships with local regulatory authorities, ensuring effective communication and proactive management of compliance expectations.
- Identify opportunities for process improvement in quality management across distributor markets.
- Develop and report key quality metrics to drive performance improvement and compliance.
Qualifications
- Minimum of 810 years of experience in quality assurance or quality management within the pharmaceutical industry, including experience with distributor markets or external partners.
- In-depth knowledge of Swiss GDP regulations and guidelines, including Swiss and EU medical requirements.
- Excellent communication skills (spoken and written) in English and French.
- At least 1 year experience as RP / RT or deputy RP / RT in Switzerland with a site that has been granted a wholesale license (WDA).
- Proven experience managing quality systems, audits, and investigations.
- Strong problem-solving and decision-making abilities, with a focus on proactive risk management.
- U