Senior Manager, Quality Country GxP Compliance (Alpine) & Responsible Perso

at  Alexion PharmaceuticalsInc

Direct technical supervision of the company’s operations to ensure the safe trading of medicinal products in Switzerland. In particular, the position holder is authorized to issue directives and instructions within scope of GDP and GMP to other personnel in the company. Responsibilities include:

• Operating the Swiss Establishment License for import with market release and ensuring the traceability of medicinal product traded within Switzerland.
• Assurance that each batch of medicinal product for the Swiss market is in compliance with the specifications in the Swiss marketing authorization with respect to its composition, manufacturing process, specifications, and quality requirements (including information on additional sampling, inspections, or controls due to possible deviations).
• Ensuring medicinal products are supplied in accordance with the rules of GMP (good manufacturing practice) and GDP (good distribution practice) in Switzerland.
• Decision on the release or non-release of a batch for the Swiss market, independently of the company management, as per MPLO art13.
• Archiving general and batch-specific documents concerning the manufacture and testing of medicinal products released onto the Swiss market, particularly the manufacturer’s batch certificate.
• Interaction with Swissmedic for quality-related topics

Employee training and allocation of responsibilities:

• Defining a training matrix and responsibilities with respect to GMP/GDP activities for employees involved in Swiss and related country operations.
• Ensuring the relevant Swiss employees are properly trained in GMP/GDP.
• Participate in training and education program for various aspect of quality assurance with focus on GMP/GDP at minimum once a year

Other responsibilities:

• Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards to the responsible cluster.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GxP guidelines.
• Provide internal auditing (self-inspection) resource to assess cluster compliance on a regular basis.
• Ensure Alexion is kept fully informed of new or emerging GxP and regulatory changes in the region.
• Manage the review and implementation of quality improvement/remediation plans for the Affiliate(s) identified through corporate as well as internal GxP audits.
• Provide quality expertise and leadership to the designated affiliate(s) and lead local/regional quality activities.
• In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate.
• Coordinate and investigate quality events in the Quality Management System software platform.
• Monitor GxP compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality.
• Act as quality liaison between the local operational groups and Corporate Quality for GxP functions and activities.
• Partner with local, regional and global operational groups to foster a proactive approach to compliance