AstraZeneca is a global, science-led biopharmaceutical pharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and employ over 59,000 people worldwide and about 20% are employed in operations across 18 countries and 30 production facilities.

AstraZeneca is proud to have a unique workplace culture that inspires innovation and collaboration. Employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

AstraZeneca in Södertälje
In Södertälje AstraZeneca has one of the largest production sites for medicines in the world. The facilities are located in Snäckviken and Gärtuna and is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organisation. AstraZeneca announced more than 2 years ago that it plans to invest approximately $285 million in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden.
Södertälje is also the location for the headquarters of AstraZeneca’s Nordic-Baltic marketing company, as well as a number of enabling functions. 4 200 roles are currently based in Södertälje and of these 3 600 within Operations. The medicines delivered from Sweden Operations account for approximately 35% of AstraZeneca’s total sales value and produce more than 30 different medicines for more than 100 markets. The export value represents ~3,5% of the total Swedish export.

Quality Organisation
The Quality organisation is led by the Site Senior Director Quality and is organised in teams to support the manufacturing facilities in Södertälje (called PET - Process Executive Team), i.e API, Turbuhaler, Oral Solid Dosage Formulation, Freeze Dried, Blow Fill Seal and Packaging. There are separate Quality teams supporting Materials, Microbiology, Laboratory Quality Control and Quality Systems. The whole Quality organisation employs 680 personnel (including QC) and each QA team consists of 15-30 professionals.

 

Quality Director/QP

We are looking to hire two experienced leaders to the Quality organisation - Quality Director/QP Turbuhaler and Quality Director/QP Materials. The role holders lead the QA function and has managerial responsibility for all activities within respective QA function and ensures cross-functional work in close cooperation with production and other support functions to deliver in compliance and on time. The role holder acts as a Qualified Person for certifying finished products.

Accountabilities
• Ensuring that the quality system in operation for the production unit is in compliance with corporate quality standards, Good Manufacturing Practice/Good Distribution Practice and Safety and Health Regulations
• Leading the QA team within the QA function, including resource management and development of personnel
• Responsible for the QA function which includes batch documentation review and batch release
• Driving the strategic direction of the QA function and contribution to the improvement and harmonization of an effective quality system within Sweden Operations

Main duties
• Resource management to ensure that sufficient and qualified personnel is in place and budgets are met
• Reporting quality status to management
• Risk management and mitigation
• Project delivery
• Ensuring that the QA function actively contributes to the leadership work within the production unit
• Hosting authority inspections

Required profile
Qualifications and profile
• Degree (Master level), within a relevant field applicable to the role such as Pharmacy, Chemical engineering etc
• Qualified Person according to LVFS
• Excellent knowledge of GMP/ compliance
• Strong leadership skills and experience as a line manager
• Experience in Lean concepts, principles and tools.
• GDP, Responsible Person wholesaler license (preferred)
• Experience working in a global environment (preferred)

Competencies, skills and capabilities
• Good leadership skills - provides others with a clear direction, delegates work appropriately, motivates and empowers others
• Takes initiative, acts with confidence and works under own direction
• Makes a strong personal impression on others, gains clear agreement and commitment from others
• Rapidly learns new tasks, gathers comprehensive information to support decision making
• Establishes good relationships and builds effective networks of contacts inside and outside the organisation

Languages
Fluent in both Swedish and English.

Contacts
For further information about the position, please contact Jarl Molin, Recruitment consultant at PeakSearch. Apply for the position at http://www.peaksearch.se.

Contact information:
Jarl Molin
jarl.molin@peaksearch.se
Mobil: +46 70 235 81 99