QA Operations Manager

Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people’s lives, all of which is underpinned by our Ipsen Way of Being.

In what sits as a pivotal role for the ongoing effectiveness of the Quality department, we now seek a QA Operations Manager to join us here in Wrexham. As a member of the site Quality Leadership Team, you will be tasked with driving and supporting changes that will ultimately improve the site Quality performance and compliance, helping to set the strategy, objectives and department goals.

What Will You Be Doing…

• To ensure an effective QA Operations service is established and maintained for all operations at the Wrexham site to that product quality, compliance and customer needs are met in an efficient manner.
• Lead a team of Quality professionals committed to supporting the delivery of site objectives
• Implement effective relationships and collaborative ways of working with BPD Quality.
• Utilize experience to coach throughout the organization to enable the Quality Culture to be fully embedded
• Build succession plans to ensure continued QA support and to secure a future talent pipeline for Ipsen.
• Establish highly effective working relationships with regulatory bodies, industry groups and other Ipsen sites to ensure quality processes meet regulatory expectations.
• Lead and provide support for projects to drive continuous improvement in order to optimize processes and performance.
• Develop and execute financial plans to deliver agreed business objectives within a defined budget.
• Manage departmental headcount within budget to meet business needs.
• Actively drive projects to improve efficiency and reduce costs.
  
  

What Are We Looking For…

• Significant proven direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and Manufacturing Operations for Biologics drug substance or drug product working on a site that produces sterile products, preferably with an experience of biological products.
• Proven experience in a QA supervisory / management position
• Solid working knowledge of regulatory requirements (MHRA, FDA, ICH, EMA).
• Ability to embrace cross-team collaboration
• Effective leadership
• Ability to manage multiple activities and shifting priorities
• Self-motivated person with the ability to identify the key issues within a complex environment, and provide clear solutions.
• A board thinker who can see the issues in technical and commercial terms.
• Excellent leader of people, with the ability to build high performing teams.
• Excellent management decision making, communication and influencing skills
  
  

Why Ipsen…

• We are a business that is experiencing exponential growth and transformation, therefore presenting a wide range of opportunities and challenges
• Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers
• A fantastic culture and working environment with many long-serving employees
• Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
• A genuine focus on the environment and sustainability – our Wrexham site is powered by 100% renewable electricity
• Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
• Awarded ‘Best Workplaces’ and ‘Best Workplaces for Wellbeing’ status in the Large Organisations category, as well as ‘Best Workplaces for Women’ in 2023.
• The pride of working for a company that directly impacts and changes lives for the better