Qualified Person (QP) - External Quality, Global Operations

at  AstraZeneca

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life!
External Quality (EQ) is a Global Quality Organization with approx. 170 people, our people are placed across all the AZ major regions globally. As a Qualified Person (QP), placed in Sweden/Södertälje, you are reporting directly into the Head of Operational Excellence and Quality management System (OPEX). Our QP is a valued member of the OPEX leadership team, and responsible to assure senior quality oversight processes are in place and performed as per cGMP requirements to protect our license to operate.
As the Qualified Person (QP) you will be accountable for Batch Certification of externally manufactured finished products. You will also act as the Regional Process Champion for Batch Review, Release and Certification process working closely with the Global BPO in Corporate Quality and aligned network and the EQ Operational release team. The scope of the role includes upholding compliance for the EQ AstraZeneca AB MIA and the API/Drug Substance registration License in relation for products manufactured by external suppliers and released by EQ. The product portfolio has a significant impact to the AZ business covering the external supply of critical products from a various range of suppliers in EU and 3rd countries, corresponding to more than 40% of AZ VoP. You will partner with and positively influence across a large and diverse partner network including global functions as an example ESM, GTO, Development Quality, Global Stability, BPD and Biologics Operations.

WHAT YOU’LL DO

Within EQ, you will, with your additional QP colleagues on the license, act as a formal QP on the AstraZeneca AB EQ MIA. You will have the accountability to assure all batches certified under the MIA are complying with the registered CMC dossier, the specific market authorization requirements and that the product has been manufactured according to the GMP standards. That the principal manufacturing and testing processes of the products has been validated to assure they have the right quality, safety, and efficacy.
You will be required to act as a modern quality professional, a role model in Quality Assurance and Quality Supplier oversight to support EQ teams. This means you will be expected to have a broad approach to assure the role and your decisions are delivered with a global view and all aspects in mind. You will also be responsible for driving and delivering continuous improvements and harmonization within Batch Release and Certification Process. Contribute to effective and compliant issue resolution with regional external suppliers, including the implementation of solutions for the resolution of quality issues at external suppliers - harmonizing and improving internal ways of working to make them more effective. You are encouraged to build value, through others, by leading and developing team members to a shared defined standard.

ESSENTIAL FOR THE ROLE

You need to fulfil the formal requirements for a QP in EU Directive 2001/83/EC and HSLF-FS 2021:102 paragraph 13, to be able to fulfil the legal basis and be eligible to act in the role as QP on the AstraZeneca AB MIA in Sweden. Your credentials will also be assessed by the Swedish Medicinal Products Agency (“Läkemedelsverket”). A MSc Pharmacy Degree, or equivalent including theoretical and practical studies in the following areas; Pharmacy, Medicine, Chemistry, Biology, Microbiology, Science and Physics/Technology/Engineering is required. Your degree must include at least the following courses:

• General and/or Inorganic chemistry
• Organic chemistry
• Pharmaceutical chemistry and/or Pharmaceutical drug analysis
• Analytical chemistry
• Physical chemistry and/or Applied physics
• General and/or Bio Chemistry
• Galenic Pharmacy and/or Pharmaceutical Technology
• Pharmacology and Toxicology
• Microbiology

And in addition to above you need at least two years’ experience from a role in pharmaceutical drug manufacturing and Quality Assurance for small and/or large molecules’ manufacturing, strong and proven leadership and business partnering skills, experience of interacting with authorities, strong collaboration, and communication skills, fluent in Swedish and English with great computer skills. You should be a Quality Professional with high integrity, strong leadership, drive and coaching capabilities, the ability to make decisions in complex situations with limited information. The portfolio has a Global spread that may present cultural challenges, travels were appropriate and a will to participate in supplier management oversight globally.

BENEFICIAL FOR THE ROLE

• Previous Qualified Person experience from business areas
• Business, financial and supply chain understanding/ awareness
• Extensive experience from Biologics and/or Sterile and OSD/Packaging manufacturing
• Ability to negotiate, resolve conflicts and influence others
• Strong Risk and Problem management skills that requires evaluative judgements
• Experience of applying Lean methodology
• Ability to work both independently and in partnership in a complex global supply chain environment