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Position: Responsible (RP) Person Germany
Reporting into: Sr. Director International Quality & Responsible Person (RP) Switzerland with Dotted Line to GM Germany GmbH

POSITION SUMMARY:

Acting as the Responsible Person (RP) of Apellis, Germany GmbH as required by § 52a AMG.
Legal Basis: § 52a AMG, §§ 1a, 4a, 6, 7a, 7b AMHandelsV, § 2.2, 2.3 EU GDP, §19 AMWHV

MAIN TASK (KEY ACCOUNTABILITIES):

• Authorized to issue instructions to all employees involved in the supply or distribution of the product for Apellis Germany GmbH according to § 2.2 AM-HandelsV, §2.1, 2.2, 2.3 EU GDP
• Implement and maintain a lean, comprehensive, and efficient QMS according to applicable ICH and GxP standards and regulations and taking into consideration the Company’s requirements (e.g., stage, activities…).
• Assume the duties under §19 AMWHV delegated from the Stufenplanbeauftragter / EU QPPV. Notify Stufenplanbeauftragter / EU QPPV when the complaint is associated with the potential Adverse Event or have safety impact.
• Ensure appropriate Product Complaint Handling (Art. 6.2 GDP-LL) and keep oversight of all product complaints of the product in Germany. Keep Stufenplan-beauftragter / EU QPPV informed about the performance of delegated activities.
• Determine need for new SOPs, assist with writing of these, and ensure their revision and GxP compliance.
• Stay abreast of new and revised governmental/industry/company regulations and eensure Apellis QMS and processes meet the requirement.
• Determine GDP related training needs, coordinate/conduct/support trainings, and ensure proper training of SOPs, QMS- and GDP- related aspects.
• Identify issues in quality system processes and improve SOPs accordingly. Encourage improvement in performance and quality.
• Ensure import and delivery of medicinal product are according to §§ 4a and 6 AMHandelsV.
• Deciding on the final disposition of returned, rejected, recalled or falsified medicinal products acc. to § 7b AMHandelsV.
• Approving returns to saleable stock with respect to § 7b AMHandelsV.
• Coordinate product recall activities. Ensure recall related notifications to the authority in case of product quality issues and execute one mock recall annually (§6.5 EU GDP).
• Quality oversight of the relevant Service Providers and 3PL / 4PLs.
• Support of the Supply Chain in the shipping validation project
• Evaluation of the temperature excursions
• Training of GXP and Non GXP German Employees.

SUPPLIER QUALIFICATION

• For suppliers relevant for Apellis Germany establish quality criteria for qualification of suppliers and develop quality questionnaires.
• Ensure qualification and release of suppliers and customers incl. requalification acc. to §4a Abs.2 Satz 3 AMHandelsV. Review quality questionnaires.
• Review and approve Quality Agreements and, or other agreements (technical agreements, service level agreements) together with other functions.
• Conduct Management Review Meetings, follow-up on status of (re)qualifications, prepare regular status reports of product and vendor performance, trending and agree upon metrics to ensure oversight.

EXPERT KNOWLEDGE:

• Knowledge of and expertise with European regulatory frameworks and processes (regional and local).
• Knowledge of pharma-specific regional and local compliance codes.
  

  LI-RL

• Escalating GxP issues of Medicinal products’ handling & distribution compliance
• Involved in the management of Deviations, CAPAs and change control system
• Qualifying suppliers and customers; Suppliers audits and Quality Agreements
• Batch Document reception, review and archiving
• Investigational & marketed products’ batch confirmation under license E
• Cross-functional collaboration to support projects
• Management; support (incl. review and approval) the execution of the risk analysis.
• Together with other functions: responsible for product recall and ensure recall related notifications to the authority in case of adverse events or product quality issues and execute one mock recall annually (Art.6.5 GDP-LL).