Senior Specialist - Device QA
Would you like to play a key role in founding and implementing a device QMS at Lundbeck and can you contribute with a solid experience within regulations in this field, then this is the perfect opportunity for you.
Lundbeck has several development projects in pipeline requiring devices/combination products and we are about to start the journey with implementing an appropriate QMS and setting the pillars for the future device development and management within Lundbeck.
The Senior Specialist, Device QA is responsible for implementation of the QMS in close collaboration with colleagues from CMC including the Device development and Management. The role is based in HQ in Copenhagen. Your solid experience and insights in device QMS will make you a natural key player in our device project teams.
Our new Senior Specialist will be an instrumental part of setting the direction for devices in Lundbeck and you have a rare opportunity to be part of the journey from the very beginning and you are guaranteed influence on the direction and setup.
The CMC business area has employees equally divided between the US and DK and is comprised of 3 divisions: CMC Development Quality (CMC Dev’t QA), Chemical & Pharmaceutical Development (C&PD) & CMC Biologics (CMCB). CMC is part of the Product Development and Supply (PDS) organization. You will be a part of CMC Dev’t QA DK in Copenhagen employing 8 colleagues.
Your job and key responsibilities / Essential Functions
- QA responsible of implementation of the device QMS
- The role shares experience and recommends best practice to support implementation of a simple and compliant QMS for Device.
- Ensuring alignment between the device and drug (CMC) QMS
- Support the improvement effort to streamline the quality documentation process.
- Promote compliance of the design and development activities and documentation by reviewing and approving documentation
- Be part of technical design reviews and support the change management process.
- Collaborate closely with the regulatory affairs team to ensure documentation required for submission are adequate and available.
- Participate in device project teams as QA representative and resource
Our preferred candidate:
- 7+ years of experience working with device quality systems
- Masters or other advanced degree in a scientific background e.g. Master of Science, or equivalent
- Proven knowledge and understanding of device and combination product regulations (MDR, 21 CFR Part 4, 21 CFR 820/210/211 etc.)
- Proven knowledge and understanding of device and combination product standards (e.g. ISO 13485, ISO 11608-series, ISO 14971, IEC 62366-1 etc.)
- Extensive experience in device development, design control, supplier approvals and audits
- Working autonomously initiating and monitoring compliance for devices
- Pragmatic and flexible to design fit for purpose solutions
- Strong execution skills ensuring timely implementation
- Strong collaboration skills
- Manages ambiguity and thrives in a dynamic and changing environment
For further information, please contact Director, CMC Dev´t QA Charlotte Ullits Houlbjerg, on CUOL@Lundbeck.com. Your application and CV should not be sent via email.
We also recommend that you have a look at our website.
Please click on the link below to apply for the job. Applications will be reviewed ongoingly and must be received no later than October 1st 2021.
Please write in your application that you've seen the job at Jobfinder.
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
Read more at www.lundbeck.com/global/about-us/progress-in-mind. ;
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.