Global GDP QA Business Partner

3 tygodni temu


Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

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Role Description

Are you passionate about ensuring the highest standards of quality and compliance in the pharmaceutical industry? LEO Pharma is looking for an experienced Global Quality Assurance Business Partner to join our Suppliers Quality team in Gdansk, Poland. If you thrive in a dynamic and collaborative environment and are driven by excellence, this role is perfect for you

Shape the LEO Pharma of tomorrow
At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities In Suppliers Quality team we share a "challenge accepted" mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your Role
As a Global Quality Assurance Business Partner you will be responsible for ensuring the quality oversight for GDP set-ups and processes according to LEO QMS, cGxP, MA's, and other relevant regulations and guidelines. Your key responsibilities will include:

  1. Acting as the main quality interface for GDP-related tasks as the GDP Global Quality Business Partner.
  2. Leading quality initiatives and strategic projects within the GDP area.
  3. Being the quality partner and ensuring quality oversight for our external central warehouse.
  4. Serving as the key contact for business stakeholders for all GDP-related questions.
  5. Overseeing regulations in the GDP domain and providing professional input to QMS maintenance.
  6. Establishing and maintaining Quality Agreements with suppliers and partners.
  7. Handling complaints, change control, deviations, and ensuring follow-up on audit and inspection observations.
  8. Presenting areas of responsibility during authority inspections.

Your Qualifications
To excel in this role, you will need:

  1. A Master's degree in natural science and a minimum of 5 years of experience working in a regulated pharmaceutical environment, preferably in a GDP role, alternatively a GMP role.
  2. Experience as a QA responsible person in collaboration with external partners, CMOs, suppliers, and internal stakeholders.
  3. Fluency in English, both verbally and in writing and excellent communication and collaboration skills.
  4. The ability to work independently with high effectiveness and deliver results of cross-functional importance.
  5. Well-developed problem-solving skills and a recognized can-do attitude.
  6. The ability to share better practices and mentor colleagues in GDP-related issues.

Your New Team
You will work closely with various internal departments, including External Manufacturing, Global Sourcing, Pharmaceutical Product Support, Regulatory Affairs, QC Laboratory, Production, Local QA departments, Group Logistics, and Customer Order Management activities. You will also engage with external stakeholders to ensure our systems and processes align with regulatory expectations and industry best practices.

Contact and Application
Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.

Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

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