Director, Country Head, Quality Assurance

Director, Country Head, Quality Assurance

Moderna

Madrid, Spain

The Role:

The Director, Country Head, Quality Assurance is responsible to ensure that the organization and monitoring of the company's vaccine/pharmaceutical operations are conducted in agreement with company standards and applicable regulations. Operations range from oversight of DS/DP manufacturing, finished product release and distribution, advertising, information, product quality, batch monitoring and recall, to the corresponding storage operations, where appropriate.

Working in collaboration with Global and Local Quality Heads, he/she must ensure that all vaccine/pharmaceutical related activities are conducted in the respect of applicable:

  • Good Practices (GxP);
  • Procedures (Policies, SOPs);
  • Marketing authorization;
  • Contracts and quality technical agreements.

Here’s What You’ll Do:

  • Serve as Company's Management Representative;
  • Be the key contact person for Health authorities, developing constructive relationship, supporting negotiations and coordination around file submission, product/process critical quality issue, and supporting filing of product/process changes;
  • Ensure Quality Agreements with local manufacturing and distribution subcontractors are in place, in use and updated as appropriate;
  • Ensure Moderna Quality system is Implemented, applied, and maintained by internal and external partners engaged in production, release and distribution of products in Spain;
  • Lead preparation of Quality Reviews (management review, Annual quality review,…);
  • Lead monitoring and management review of Quality KPIs and ensure appropriate actions are taken to mitigate risks and resolve issues in due diligence;
  • Develop and administer department budgets, schedules, and other administrative functions;
  • Ensure procedural/operational (SOPs,…) documents are created, updated and applied;
  • Support, as requested, GMP, GCP, GVP or other regulatory inspections;
  • Report to the Local Pharmaceuticals Agency any placing on the national market of a medicine which he considers to be falsified, for which he ensures the distribution;
  • Lead local production and distribution Risk analysis;
  • Ensure appropriate Complaint, Deviation, Change and Recall management;
  • Ensure appropriate management of medical queries;
  • Manage vaccine/pharmaceutical subcontractors to ensure that the transportation conditions guarantee the appropriate conservation, integrity and security of the products for local market;
  • Ensure that manufacturing of drug substance and drug product by local CMOs is executed in agreement with regulatory, quality system and quality agreements requirements;
  • Ensure Monitoring of medical samples;
  • Ensure implementation and monitoring of the distribution system (contracts, specifications, etc.);
  • Ensure stock monitoring (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.).

This list is non exhaustive. Other missions may be added.

Here’s What You’ll Bring to the Table:

  • MSc or PhD in relevant scientific discipline (biotechnology, biochemistry, chemistry, pharmacy,…);
  • +15 years Significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area);
  • Experience executing Qualified Person responsibilities in (bio)pharma is a plus;
  • Strong operational excellence and quality mindset, with working knowledge of relevant local and international regulations and ICH, ISPE, ASTM standards/guidelines;
  • +2 years Experience in hosting and collaborating with national or international regulatory agencies;
  • Experience leading QA department of pharmaceutical business and quality governance is a plus;
  • Experience leading team/budget (functional or project acquired experience);
  • Ability to work across multiple business functions to build consensus;
  • Excellent interpersonal skills;
  • Outstanding communication skills (verbal and written);
  • Experience working with CMOs, CLOs, vendors preferred;
  • Ability to conceptualize, analyze, plan and manage in a fast-paced environment;
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment;
  • Ability to navigate through ambiguity and rapid growth and adapt to change.

Language skills:

  • Fluent Spanish;
  • Fluent business English.

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© EuroJobsites 2022

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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