Quality Assurance Specialist for CMOs
1 week ago
Standards for CMOs
Lundbeck seeks a Quality Assurance Specialist to standardize its use of Contract Manufacturing Organizations (CMOs).
A key aspect of this role is driving improvements to our products and processes at CMOs using risk assessment skills. The successful candidate will leverage their expertise to determine when "good enough" truly is good enough, allowing Lundbeck to be the best possible customer and partner for CMOs.
Your new role
You will support the standardization of CMO use globally and drive product and process improvements in a dynamic, international environment. As part of a team with a vision to be the best possible customer for CMOs, you will utilize your risk assessment skills to standardize our quality level.
The team at Lundbeck actively explores diverse perspectives and challenges the status quo. We ask open questions and listen actively to ensure everyone feels free to share their views.
You will take on the role of Qualified Person (QP) delegate, supporting the release and daily operation of the CMO cell at Lundbeck and ensuring the release of life-saving products to patients worldwide.
Your future team
You will have an important role in developing and enhancing processes. You will excel in dialogue and communication at all organizational levels, prioritizing patients, acting with integrity, and holding yourself and others accountable to meet commitments with clear effective decisions.
In this role, you will contribute to the most dynamic CMO team in Danish pharma, working collaboratively to achieve excellence and be courageous in stepping up to address difficult issues.
You will enjoy the opportunity to make independent decisions with full support and empowerment from your team.
You will report to the Director of Quality Assurance External Manufacturing.
What you bring to the team
- A background in Quality Assurance and thorough experience working with CMO-manufactured pharmaceuticals
- Experience working with projects and change management preferably within CMO manufacturing and possible experience as an auditor
- An effective communicator on all levels of the organization with a personal drive
- The ability to proactively handle multiple tasks simultaneously together with a positive attitude towards work assignments, colleagues, and stakeholders
- Education: A master's degree in pharmacy or a related field with 5+ years of relevant experience
You are curious and actively exploring diverse perspectives, challenging the status quo, asking open questions, and listening actively to ensure that each person feels free to share their views. Also, you are courageous in stepping up to address difficult issues and adaptable in your approach.
You are eager to develop both personally and professionally, enhancing your skills for the benefit of yourself and Lundbeck's patients. We focus on the individual, creating the best possible working conditions for you.
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability, and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.
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