Quality Control Manager, Advanced Therapies
2 maanden geleden
This position will be based at our Leiden site.
- Initially a 12-month fixed-term contract, with the intention to extend.
Change lives for the better.
THE OPPORTUNITY
We are passionate about the development, production, and marketing of antibodies/cell therapy medicines to prevent and combat diseases. At the Leiden and Sassenheim site, dedicated and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Within the QC laboratories of the JJIM Supply Chain in Leiden, the QC- AT lab is responsible to support the production activities in Sassenheim and perform the QC release and stability testing for the site and other production sites in the Advanced Therapies Supply chain network.
The responsibilities & impact YOU will have:
- Leading a team of Supervisors and Technical specialists in an efficient and effective manner with Quality mindset ensuring core and context QC testing processes are meeting the customer commitments.
- Ensures that GMP/GLP guidelines, compliance best practices, EHSS regulations are applied and followed by the team members.
- Establish and monitor team KPI’s and provide matrices to site quality meetings and other requests.
- Manages the budget of the group and allocations and provide input for the OPEX/CAPEX budget.
- Identify and support continuous improvement efforts in the laboratory in collaboration with the QC management.
- Has a leading role for QC during Internal and regulatory audits and is responsible for the implementation of follow up corrective actions.
- Train, develop, coach and mentor direct reports.
- Evaluates performance and provides opportunities for growth, conduct performance appraisals, and ensure alignment of G&O of direct reports to the company objectives.
- Promotor of Diversity; Equity and Inclusion within the team.
**Qualifications**:
We would love to hear from YOU, if you have the following essential requirements:
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:
- Minimum qualification is bachelor’s degree in relevant discipline with 8-10 years related experience or master’s degree in relevant discipline with 4-8 years related experience.
- Experience in Quality Control.
- Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, etc.).
- Organizational planning and problem-solving experience.
- Experience with principles of Process Excellence, Lean manufacturing, etc is a pre.
- Strong communication and presentation skills.
- Excellent knowledge of English.
This is what awaits YOU at J&J
This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the ~1000 people who work here, or you’re considering joining the team, we offer:
- Flexible working hours.
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment, including operating globally.
- Opportunities to work on challenging projects and assignments.
- Possibilities for further personal and professional development/education.
- Excellent Benefits.
Closing date: Thursday, 26th of September, 2024.
Being part of Johnson & Johnson can change everything, including YOU
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
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