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Director QA and Qualified Person to AstraZeneca

Södertälje

Recruitment Life Science

Welcome to join the new strategically important business unit in Sweden to support global supply of existing products and the impressive new portfolio.

The arena

Global Biologic Operations is establishing a new strategically important business unit in Sweden to support global supply of our existing biologic products and the impressive new product portfolio. The business environment is dynamic with a high pace of change. Your arena includes collaborating cross functionally in an international environment and organization. Ensuring our products are right first time every time for our patients is an imperative at AstraZeneca and will be key within your arena.

The role

We are recruiting a QA Director and Qualified Person to join Sweden Biologics Quality team, in Södertälje. The position is held within the Global Quality Organization and will report to the Site Quality Director. You will be accountable for implementing and lead the Quality Operations function, and become part of the site Quality Leadership team. You are to fulfil requirements, duties and responsibilities of a Qualified Person. 

Main duties and Responsibilities

  • Implement and proactively lead the Quality Operations Function, to ensure results, delivery against targets & KPI´s and continuously improve.

 

  • Ensure products as well as execution of business processes, standards and systems are in compliance with AstraZeneca procedures and competent authority requirements (LVFS, EMA, FDA, ICH etc). 

 

  • Ensures QA capabilities to proactively support the business and assure quality oversight. Provide direction, development, and performance management to QA professionals within the function. 

 

  • Act as Qualified Person. Responsible for release of products in compliance with regulatory requirements and AstraZeneca standards. Ensures delegated QPs are trained to current standards. 

 

  • Responsible for audits within own area, suggest responses and follow up on corporate and Health Authority Inspections. 

 

  • Act as an escalation point for quality incidents and manage issues through to resolution together with AZ quality organisation.

 

  • Lead significant cross-functional projects, developing and implementing improved standards and ways of working.

 

  • Responsible for SHE and ensures Budget adherence.

Essential Requirements

  • Considerable experience, minimum 10 years, from pharmaceutical industry, including quality, manufacturing, development or regulatory.
     

  • Competent leader and people manager with several years’ experience of leading teams.​

  • Possesses a background in biologic or aseptic/sterile manufacturing. 

 

  • Master’s degree in Pharmacy, Chemistry, Engineering or relevant field

 

  • Satisfying requirements for Qualified Person (LVFS 2004:7)

 

  • Act as Qualified Person. Responsible for release of products in compliance with Marketing authorisation and AstraZeneca standards. Ensures delegated QPs are trained to current standards.

 

  • Strong knowledge and ability to apply GMP/GDP and major regulatory authority regulations.

 

  • Has strong interpersonal skills and ability to collaborate and interact at multiple levels within a global organization, with business partners and competent authorities.

  • Possess excellent communication skills. Fluent in Swedish and advanced in English.

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, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 

How to apply

Welcome to apply and contact either one of us for more information. We look forward to receive your application/CV no later than August 30.

Leif Olsson

+46 (0)70 699 47 80

Torbjörn Ströberg

+46 (0) 703 77 87 74

Ann-Katrin Broman

+46 (0) 707 55 50 94