Qualified Person

Title:

Qualified Person

Company:

Ipsen Biopharm Ltd

Job Description:

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
• Employee Care: We care for our employees, who are the ambassadors making a real difference.
• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

Our Wrexham manufacturing facility is the home of our Neuroscience asset, and our largest site in the UK. The Qualified Person is named on both the Ipsen Wrexham MIA and IMP licenses.

Key Responsibilities

• Execute certification of finished product batches and release in accordance with UK and EU regulatory requirements for those batches requiring QP certification in accordance with existing Quality Technical Agreements. 
• Confirm compliance of intermediate stages of manufacturing either personally or through agreement with other IBL QPs and delegation.
• Manage GMP elements of product development activity including the introduction and disposition of clinical material.
• Drive a “Commitment to Quality” culture through leadership and action. 
  • Provide necessary framework within the Quality Operations department to execute a “Commitment to Quality” culture;
  • be a role model for decision-making that puts quality first; and reinforces the importance of quality through words and actions.
• Provide leadership & mentorship in quality matters for the site
• Provide quality assessment of regulatory submissions, variations and response to questions as necessary.

Qualifications

• Degree or equivalent in a relevant scientific discipline (e.g. biology, biochemistry, chemistry, pharmacy)
• Eligible to Act as a Qualified Person within the pharmaceutical industry

Experience:

• Demonstrate significant pharmaceutical experience preferably in sterile manufacturing and including work within Quality Assurance

Languages:

• Fluent written and spoken English.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.