Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
The Site GxP Quality Sr. Manager will be responsible for managing the implementation and execution of the Corporate Quality System at the designated affiliate(s) within Alexion. The Senior Manager will be the primary Quality contact in the specific designated country, and will have strong experience in GxP’s, quality systems and Pharmacovigilance areas as well as the ability to function independently and in a matrix environment.
The Senior Manager should be eligible as Responsible Person, RP, and will be named on the Alexion Sweden Distributions License.
In addition the Sr. Manager will be responsible for leading Quality activities within the Nordics and for line management of GxP Quality Manager(s) within the Nordics.
- In coordination with the Director, Central and Northern Europe Regulatory and Quality Affairs, the other Managers, Quality Assurance and related peers within the Global Quality organization, the Sr. Manager will work to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, associated procedures and standards and local regulations.
- Provide Quality support for territory expansion and new product introductions. This includes the maintenance and necessary updates to QAGs (Quality Agreements), initiation of audits, and support of required Quality documentation
- Provide leadership and resource management support to Corporate Quality and the designated Affiliate
- Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GxP and PV guidelines
- Ensure adherence to Alexion procedures to vendor oversight, periodic KPI review and appropriate risk assessment and mitigation
- Coordinate Self-inspections and internal auditing resource to assess site compliance on a regular basis. Perform self-inspections
- Ensure Alexion, local and global, is kept fully informed of new or emerging GxP GMP/GDP and regulatory changes in their region.
- Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GxP audits
- In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
- Monitor GDP, GxP and Pharmacovigilance 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 GDP/GXP/PV functions and activities
- Partner with local, regional and global operational groups to foster a proactive approach to compliance.
Responsible Person (RP) responsibilities
Act as primary Responsible Person (RP) on Alexion Swedish Wholesale Dealers License and ensure that the provisions of the license is observed in accordance with Swedish regulation LVFS2014:8 and the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01), as follows:
- Ensure that the country operations do not compromise the quality of medicines
- Ensure a quality management system is implemented and maintained
- Focus on the management of authorized activities and the accuracy and quality of records
- Ensure initial and continuous training programs are implemented and maintained
- Coordinate and promptly perform any recall operations for medicinal products
- Ensure relevant customer complaints are dealt with effectively
- Ensure suppliers and customers are approved
- Approve any subcontracted activities which may impact on GDP
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- Keep appropriate records of any delegated duties
- Decide on the final disposition of returned, rejected, recalled or falsified products
- Approve any returns to saleable stock
- Ensure 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.
- 8 years+ of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GxP compliance.
- Good knowledge of government regulations, laws and guidelines (local Swedish regulations, EMA) pertaining to GxP and Pharmacovigilance required
- Knowledge of pharmacovigilance AE reporting systems and regulations required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems
- Strong leadership ability
- 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
- Experience in using computerized system for Change Control, Deviation and CAPA management
- Fluent Swedish and English language skills
Bachelor’s Degree in physical /life science or pharmacy; Advanced degree preferable
- Extensive experience and knowledge in applicable regulations for wholesaling activities which includes, but are not limited to, GDP and Swedish regulations
- Meet requirements as Responsible Person in Swedish regulations and approval as named RP on WDA
- Experience and knowledge in applicable regulations for pharmacovigilance which include, but are not limited to GVP
- Fluent in English
The location of the position is in Stockholm/Sweden.
How to apply
If this sounds interesting to you, we look forward to receiving your online application by uploading your CV and cover letter in English. For more info please contact:
Catharina Bergold, Recruitment Consultant, firstname.lastname@example.org, tel +46 70 217 98 79
Torbjörn Ströberg, Recruitment Consultant, Torbjorn.Stroberg@hpsearch.se, tel + 46 703 778 774
Welcome with your application!
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.