Head of Global Quality Management Systems and IT Quality Compliance
Job Description
Your Skills and Experience
Education/Qualifications
- BS Degree in Science, Life Sciences, Engineering, Pharmacy or related.
- Minimum of 15 years’ pharmaceutical experience in a Quality or Operations role in a GMP environmentin a large pharma company
- At least 5 years in leading direct reports in a site Quality unit, Quality operation and Quality Control
- Expert knowledge and understanding of cGMP, Risk Management, and in the implementation of Pharmaceutical Quality Management Systems
- Expert knowledge in regulatory standards in Pharmaceutical Industry, including requirements and expectations of global regulatory bodies, in particular but not limited to US FDA, and EU authorities.
Critical skills/capabilities:
Professional:
- Practical knowledge of Global Compliance and Regulatory requirements, Industry, cGxP and associated guidelines, Quality System, IT quality compliance and Risk Management.
- Direct interaction with health authorities.
- Experience working in a large, complex matrixed environment with global processes & governance structures; practical knowledge of pharmaceuticals and R&D.
- Practical knowledge on risk management.
Essential: Strong critical thinking/problem-solving skills to navigate ambiguous situations; Strategic thinking; Excellent storytelling and presentation skills; Cross-functional collaboration and stakeholder management; Effective communication; Strong relationship and senior stakeholder management capabilities
Leadership: Strong leadership, change management & influencing skill; Decision-making under uncertainty skills; Ability to drive transformational change in a large/global/matrixed environment; Proven talent management & people development capabilities (incl. coaching and mentoring); Ability to create an engaging & inclusive work climate and a culture of appreciation and trust; Ability to set a vision and drive organizational change and innovation; Ability to manage effectively complexity within the organization (shifting timelines, projects, priorities).