QA Lead

Title:

QA Lead

Company:

Ipsen Biopharm Ltd

Job Description:

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.

The role of the QA Lead in the QA Ops department is to provide expert level quality support to the Ipsen business, primarily based at the Ipsen Wrexham site.

The QA Lead role focuses on GxP aspects of customer complaints, requiring expertise in:

• The Pharmaceutical Quality System, including Global Quality Activities, QSEB, and JAF meetings.

• Acting as an audit contact and subject matter expert during site inspections.

• Serving as the Site Quality interface for all Wrexham Commercial Products with Ipsen Global counterparts.

What you will be doing…

• Build internal and external working relationships to allow management of Complaint cases. Quality Com Ops, Joint Assessment Forum, Quality Safety Evaluation Board, Global Patient Safety Team, Medical Information Team, All Complaint Managers, MHRA, FDA.

• Communicate complaint data, trends and improvement activities within the local and global Ipsen community. Support the investigation into product complaints and the development of CAPA to reduce the risk of recurrence.

• Provide expert quality input/solutions based on knowledge of GMP, QRM and relevant manufacturing processes to Ipsen affiliates, partners, and regulatory agencies & Health Authorities.

What we are looking for…

• Bachelor's degree is the minimum requirement.

• Extensive experience in Pharmaceutical Quality.

• Prior work history of complaint management, quality compliance and of packing technology.

• Knowledge of Global Regulations in relation to Product Security.

• Capable of communicating effectively with internal and external partners, health authorities, and representing Ipsen at industry events.

• Able to provide training to cross functional teams on Complaints and product security topics.

• KPI management

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.

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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.