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

Reports to: Associate Director, CENE Regulatory Affairs

Location: Baar, Switzerland

Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Alexion is evaluating other potential indications for its marketed drug and is developing additional highly innovative biotechnology product candidates across multiple therapeutic areas.

Position Summary

The main purpose of the position is to fulfill the technical responsibilities of the Swiss Responsible Person (RP, Fachtechnisch verantwortliche Person (FvP)) in relation with the Swiss Establishment License held by Alexion Pharma GmbH in compliance with Swiss Law SR 812.212.1, Medicinal Products Licensing Ordinance (MPLO). The function holder also maintains the quality management system (QMS) for all GMP/GDP activities for Switzerland.

The Swiss RP must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance. To ensure compliance with the legal requirements, the direct supervision of the company by the RP must be guaranteed at any time. In addition, the Senior Manager, Quality Country GxP Compliance (Alpine) acts as the quality lead for Switzerland and Austria (Alpine Region).

Responsibilities as Senior Manager, Quality Country GxP Compliance (Alpine) & Responsible Person (Switzerland)

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.

Management of the local Swiss Quality Management System (QMS), including:

• Implementing, monitoring and maintaining the local QMS for all GMP/GDP activities for Switzerland.
• Setting-up and updating quality agreements (QAGs), in collaboration with Alexion Global QA, for delegated or subcontracted activities.
• Maintaining the Swiss Site Master File.
• Ensuring Alexion global standards are implemented locally.
• Remaining informed of regulatory developments impacting the Swiss establishment license and implementing any necessary changes in due time.
• Evaluating the global product quality review (PQR) to verify that the product and processes remain in compliance with the Swiss marketing authorization.

Product quality complaints, quality defects and product recalls:

• Monitoring local complaints from the Swiss market and notifying the Global Complaint Handling Unit (CHU) of all local complaints.
• Notifying the relevant pharmacovigilance function of any product quality complaint from the Swiss market with a potential medical component (adverse event).
• Evaluating the classification of quality defects and ensuring they are reported to Swissmedic according to Swiss requirements.
• Contacting Corporate QA regarding potential product recall issues in Switzerland.
• With support from Corporate QA and Regulatory Affairs, drafting and approving recall communications and submitting them to Swissmedic, as appropriate.
• Assisting with local recalls from the Swiss market and ensuring that affected batches are placed in quarantine.
• Approving recall reports.
• Preparing for and coordinating any follow-up Swissmedic inspection as applicable.

Product returns:

• Approving the disposition status of medicinal product returned from the Swiss market.

Deviation, change control and CAPA management:

• Recording and processing local deviations, changes and CAPAS in the QMS.
• Reviewing or approving as local QA contact any deviations, CAPA or change control opened in another Alexion division which impacts the local organization or the Swiss establishment license.
• Monitoring deviations, local CAPAs, change controls and tasks until completion.

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.

Vendor Management:

• Acting as a contact point for any quality topic and participating in quality or business review meetings.
• Participating in and/or approving local distributor qualifications and audits.

Self-inspections:

• Ensuring self-inspections are performed at appropriate regular intervals according to a predetermined risk-based schedule.
• Implementing CAPAs as necessary to address self-inspection findings.

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.

Qualifications

According the Swiss MPLO (Art. 17 and 18) of 14 November 2018 and technical interpretation I-SMI.TI.17, the Responsible Person must demonstrate the appropriate level of education, knowledge, experience, trustworthiness, and independence.

For the education, higher qualifications in natural sciences (university or equivalent) are valued; and regarding manufacturing or market release of dosage forms, emphasis is placed on pharmaceutical or biological-natural sciences knowledge.

Depending on the activities to be performed and the education of the RP, one to four years of GMP and GDP experience is required as well as technical knowledge of processes for which the RP will be responsible.

• GMP experience is required for the import, including market release, of medicinal products.
• GDP experience is required for the import, including market release, and wholesale of medicinal products.

This experience can be acquired:

• By activities where the individual is in charge of, or partially responsible for, the manufacturing of medicinal products or ATMP (GMP), or the wholesale of medicinal products (GDP);
• By involvement in quality assurance work within a company/institution that manufactures medicinal products or transplant products.

Other requirements:

• The position holder must speak German (the official local language of the canton where the inspection takes place and where the licensed site is located).

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.