AstraZeneca Pharmaceuticals LP Quality Supplier Manager – Certification Team (Sweden or UK) in Macclesfield, United Kingdom
At AstraZeneca, every one of our employees makes a difference to patient lives everyday.
Big success can come from seeing potential in something small. We empower our people to seek these out, and we support them to pursue the opportunities they find.
We are now seeking for a Quality Supplier Manager to join the Global Supplier Quality (GSQ) team in Södertälje or Macclesfield.
The new Global Supplier Quality (GSQ) organisation is an evolution of the Global External Sourcing Quality team, combining global and local supplier management across the AstraZeneca Operations network. The organisation has been created in response to the Operations 2020 strategy and Operations Quality 4S – Simplify, Standardise, Share and Sustain. This allows us to share operations best practice, reduce supplier management compliance risks and drive value by capitalising on synergies.
GSQ will provide Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations and will launch in January 2018. The scope of the organisation includes outsourced API, Biologics CMOs, Direct Materials, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.
As a Quality Supplier Manager (QSM) you will hold responsibility for the Quality management of assigned Quality system and compliance activities for GSQ supply chains and suppliers.
You will be responsible for all Quality activities that directly support execution of assigned Quality Management System elements. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: certification reports, change control, product quality complaint, S&L complaint and deviation investigations, product release, quality system element governance as either BPO or deputy BPO, SOP management, stability data entry and management, Supply Chain Assurance (SCA) administration, quality risk management, Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between GSQ and AZ Operations Sites.
Within the Global Supplier Quality (GSQ) organization you will hold responsibility for the oversight and ownership of Quality System(s). You will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories.
In addition, the preparation and submission of periodic Supplier Quality Assessments and performance of Regulatory Agency interactions as needed. Regulatory Agency interaction includes assisting in the preparation for and management of Regulatory Agency inspections at External Suppliers and AstraZeneca Sites (when external suppliers are within the inspection’s scope).
You should also possess Quality Technical capabilities at the required level you may serve as subject matter experts (SMEs).
This position requires strong cross-functional ways of working with non-Quality members across the PCO.
You should have the ability to travel nationally and internationally as this will be required for approximately 10% of your time. AstraZeneca career Level C or D depending on experience.
Minimum Requirements - Education and Experience
Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
Able to demonstrate strong knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
A strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
Experience of working cross-functionally and managing significant improvement initiatives (e.g. project management skills).
Skills and Capabilities
With the ability to work independently under your own initiative, you will be a strong influencer with good problem-solving skills.
For further information regarding the role, please contact Joanne Allen tel +44 7585 983599.
Please submit your application in English no later than June 6, 2018. Applications will be reviewed continuously.
In Södertälje, Sweden, is AstraZeneca´s largest global production and distribution facility, one of the world's largest manufacturing units for pharmaceuticals. In total, we employ approximately 4,100 people, of which 3,500 are working in the manufacturing facilities.
In Södertälje, we are also investing about $285 million in a new high technology facility for manufacturing of biomedicine, which enables us to combine our expertise within Biomedicine and our well-established, first-class production culture.
Macclesfield, in the north-west of England, is AstraZeneca´s second largest manufacturing site and our European centre for packing. Some 1,800 people are employed at our Macclesfield site, where we manufacture, pack and distribute our medicines to 130 global markets.Effective manufacturing processes are vitally important to our work, so we´ve introduced new techniques at Macclesfield which have increased efficiency significantly.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other.