Site Quality Head Marburg (m/f/d)

Posted:
8/5/2024, 9:35:47 PM

Location(s):
Queensland, Australia

Experience Level(s):
Senior

Field(s):
Product

Site Quality Head Marburg (m/f/d)

The role is part of the Site Leadership team

The deadline for the job posting is the 27th of August in 2024

Job purpose:

To provide strategic leadership and direction for the site's Quality function, ensuring the highest standards of product quality and compliance with GSK corporate policies and regulatory standards. The role is accountable for the quality of all products released from the site and for representing GSK in health authority interactions.

Key responsibilities:

  • Strategy Deployment: Serve as a member of the site leadership team, actively contributing to strategy deployment to support GSK objectives
  • Quality and Compliance Strategies: Develop and implement quality and compliance strategies and initiatives, ensuring full deployment of GSK’s Quality Management System (QMS)
  • Continuous Improvement Culture: Foster a culture of continuous improvement, developing and monitoring key quality metrics to drive performance
  • Quality Leadership: Provide leadership and direction in all Quality related matters, ensuring operational business compliance with cGMP and regulatory requirements
  • Team Development: Lead and develop the Quality organization on site, making decisions that prioritize patient safety and product quality
  • Strategic Quality Planning: Develop and execute a long-term quality strategy that aligns with the overall business objectives, ensuring that quality considerations are integrated into the site's strategic planning and decision-making processes
  • Regulatory Compliance: Maintain a state of inspection readiness by staying abreast of regulatory changes and trends, and ensuring that the site's quality systems and processes are robust and compliant with current industry standards and practices
  • Quality Culture and Employee Development: Champion a strong quality culture throughout the site by promoting quality awareness, accountability, and continuous improvement. Develop and mentor quality personnel to build a pipeline of talented quality professionals capable of supporting the site's current and future needs

Professional and technical Qualifications:

  • University degree in natural sciences or related disciplines, with extensive experience in pharmaceutical or biological production environments
  • Experienced with roles in operations within the pharmaceutical industry
  • Strong knowledge of FDA/EU/ICH/CDN/AUS guidelines, with the ability to navigate complex regulatory requirements
  • Proven leadership capabilities, with experience in managing large teams and complex projects
  • Excellent interpersonal and communication skills, with the ability to engage effectively with stakeholders at all levels
  • A track record of making risk-based decisions that prioritize patient safety and product quality

Preferred Qualifications:

  • Experience in leading cross-functional teams and driving organizational change
  • Strong knowledge of good manufacturing practices and data integrity
  • Demonstrated ability to challenge the status quo and drive continuous improvement
  • Ability to make risk-based and autonomous decisions
  • German language skills are desired, but not mandatory

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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