Senior Manager, GxP Quality, Responsible Person – The Netherlands

Senior Manager, GxP Quality, Responsible Person –
The Netherlands

Reports to: Senior Director, RQA CENE
Location: Den Haag, The Netherlands

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 Senior Manager, GxP Quality will be responsible for managing the implementation and execution of the Corporate Quality System for Alexion’s Netherlands activities. The Senior Manager, GxP Quality will be one of the Quality contacts in the region and act as the Responsible Person on the Wholesale Distribution License in The Netherlands in accordance with EU Directive of 5 November 2013 on Good Distribution Practices of Medicinal Products for Human Use (2013/C 343/01) and the Netherlands Medicines Act.

Principal Responsibilities
• In coordination with the other Managers, Quality Assurance and related peers within the Global Quality organization, ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards at the site level.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP guidelines/ regulations.
• Provide leadership and resource management support to Corporate Quality and their designated Affiliate.
• Provide internal auditing resource to assess site compliance on a regular basis
• Ensure Alexion is kept fully informed of new or emerging GDP and regulatory changes in their region.
• Manage the review and implementation of Quality Improvement/remediation plans for their Affiliate identified through Corporate as well as internal GDP audits.
• Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities.
• In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate.
• Monitor GDP 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 Global Quality for GDP functions and activities.
• Provide local quality support where required.
• Partner with local, regional and global operational groups to foster a proactive approach to compliance.

Responsible Person (RP) responsibilities (Alexion Pharma
Netherlands)
• Act as primary Responsible Person (RP) named on the Alexion Pharma Netherlands’ Wholesale Distribution License and ensure that the provisions of the license are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01), as
stipulated in the “Geneesmiddelenwet” of 8 februari 2007 (article 35-37) as follows:
• Ensuring that a quality management system is implemented and maintained;
• Focusing on the management of authorised activities and the accuracy and quality of records;
• Ensuring that initial and continuous training programmes are implemented and maintained;
• Coordinating and promptly performing any recall operations for medicinal products;
• Ensuring that relevant customer complaints are dealt with effectively;
• Ensuring that suppliers and customers are approved;
• Approving any subcontracted activities which may impact on GDP;
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
• Keeping appropriate records of any delegated duties;
• Deciding on the final disposition of returned, rejected, recalled or falsified products;
• Approving any returns to saleable stock;
• Ensuring that any additional requirements imposed on certain products by national law are adhered to;
• The Responsible Person should fulfil their responsibilities personally and should be continuously contactable. The Responsible Person may delegate duties but not responsibilities.

Deputy RP responsibilities
Alexion Pharma Belgium
• Act as deputy Responsible Person (dRP) for Alexion Pharma Belgium to ensure that the provisions of the license are in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01) and the Belgian Royal Decree of 14 December 2006, article 90-99, 99 bis, as follows:
• Support in the maintenance of the quality management system;
• Conduct trainings;
• Carry out self-inspections;
• Perform recall operations for medicinal products;
• Handling customer complaints;
• Customer approvals;
• Compliance with additional requirements imposed on certain products by national law.

Alexion Sweden
• Act as deputy Responsible Person as delegated separately by the Responsible Person on the Swedish Wholesale Distribution License.

Qualifications
• 5+ years of hands-on Quality Assurance / Compliance experience in pharmaceutical/ biotech industry.
• Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Strong leadership ability.
• Good knowledge of government regulations and guidelines (local, EMA) pertaining to GXP required
• Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
• Exceptional communication and interpersonal skills
• Ability to work globally in a matrix environment
• Ability to influence senior management, peers and other colleagues without direct reporting lines
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
• Ability to multi-task and prioritize work
• Strong organizational ability
• Demonstrable computer skill

Education
• Master's Degree in pharmacy, medicine, veterinary medicine, chemistry, biology, biomedical science
• Certificate GDP training

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.