Senior Manager Quality Assurance - Nordics

Senior Manager Quality Assurance - Nordics

AbbVie

Stockholm, Sweden

Job Description

In your role as Senior Manager Quality Assurance - Nordics it is your responsability to manage Nordics LRD Quality Assurance System in line with global, regional and local quality and regulatory requirements. You are operating according to regional procedures except where legal and other specific local requirements dictate. You perform the role of Responsible Person for Wholesale Distribution Authorisations, named with the Danish and Swedish Competent Authority.

In collaborations with corporate QA and in-country QA, you are managing all activities associated with the investigation of significant non-conformance relating to pharmaceutical products and medical devices, within the region and ensure adequacy and completeness of risk evaluation, product containment, distribution reconciliation, product recall and recall effectiveness, as necessary.

Key Responsibilities

  • Manage Quality Stream activities for development of Allergan QMS in Sweden, Norway, Finland and Denmark and where applicable new, go-direct markets within NORDICS;
  • Develop QMS to comply with standards, regulations, corporate, regional and local quality requirements;
  • Ensuring compliance with Corporate QA, GDP, GMP and national requirements;
  • Ensure consistent implementation of QMS across the region, and promotes continuous improvement culture on site;
  • Manage QA self-inspection programme for GDP, technical agreements with distributors and manufacturers, quality and vigilance including auditing on behalf of Global Quality, as required;
  • Internal audit program including audit schedules, audit commitment tracking;
  • Training and development of quality personnel;
  • Local complaint handling for all pharmaceuticals and regional deviation/CAPA system;
  • Document control and related training systems and Manage significant non-conformance and recalls;
  • Perform NORDICS Quality Management LRD Review and related metrics;
  • Host inspections by local regulatory authorities and Notified Bodies;
  • Coordinate new product introductions.

Qualifications

  • Degree level – Life sciences ideally Pharmacist or Chemist or Biologist;
  • 5 plus years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs;
  • Experience with GDP inspections and third party audits;
  • Understanding of pharmaceutical manufacturing and third party logistics (including familiarity with various analytical techniques) a strong asset;
  • Experience of quality requirements through the whole value chain: Manufacturing, Third Party Distribution and Post Marketing activities;
  • Confidence and assurance in working with commercial, regulatory and quality colleagues;
  • Knowledge of Quality Management requirements for MAH and distribution;
  • Experience in Quality System Management and writing SOPs, as necessary;
  • Able to interact with Competent Authorities and Notified Bodies, ideally hosting of audits and in managing small quality teams;
  • Experience in European Union GDP requirements for medicinal products and conducting audits to ensure compliance of QMS;
  • Solid decision making skills;
  • Analytical and problem solving skills;
  • Detail Quality oriented mind-set;
  • Ability to identify, define and resolve problems using a structured methodology;
  • Good interpersonal skills and the ability to influence others without formal authority;
  • Excellent communications skills (verbal, written, listening, presentation etc.);
  • Concise and persuasive in the description of the different QA situations;
  • Ability to work effectively and collaboratively across global organisation and cross functions;
  • Strong IT system application skills e.g. MS Office application and other electronic database systems.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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