At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP). The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.
Partner with quality management to support continuous improvements of key Quality Systems (Deviations, CAPAs, Change Control) in support of both commercial and clinical products.
- Manage the deviation and Corrective and Preventive Action (CAPA) programs and track the timely closure of internal and CMO deviations and CAPA's
- Serve as a back-up change control administrator for internal and CMO change controls and assist in closure as needed
- Track, trend, and prepare quality metrics for the Quality Management Review meetings
- Participate in Subject Matter Expert (SME) based teams to resolve technical Quality related issues
- Collaborate with multiple CMOs and cross functional groups including: Manufacturing Science and Technology, Quality Control, Regulatory, and Process Development
- Write SOP's and assist with Quality systems development, maintenance, and improvement
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited BS/BA degree and 5 years’ experience in the pharmaceutical, biotech or medical device industry, or a combination of education and experience totaling 9 years in the pharmacuetical, biotech or medical device industry.
- Experience with quality systems and writing SOP's
- Adept at managing multiple priorities in a fast-paced, regulated environment
- Ability to communicate effectively throughout all levels of an organization
- Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
- Strong understanding of Quality Systems and experienced in deviation and change control management
- Excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
- Strong computer skills, particularly with Microsoft Office Suite and Adobe Acrobat
- Team player with the ability to work collaboratively with other functions to executes Quality System requirements and complete
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredite bachelor's degree in Life Sciences
- Commercial experience working in a quality organization
- Experience working with CMO's
- Compliance assessments
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
Quality Assurance Specialist