Lundbeck

Senior Quality Assurance Specialist, Biologics Commercial Quality Operations

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Job Description

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!

SUMMARY:
Lundbeck Seattle BioPharmaceuticals is seeking an experienced and highly motivated individual to join our Quality Operations team. The ideal candidate has experience with quality systems related to change controls, deviations, product complaints, Annual Product Review and lot disposition and is adept at managing multiple priorities in a fast-paced, regulated environment. This position requires an experienced candidate able to communicate effectively with internal personnel, Contract Manufacturing Organizations (CMOs) and Contract Test Laboratories (CTLs) to mitigate potential quality issues. This position will also partner with quality management to support continuous improvements of quality systems in support of commercial biologics products.

ESSENTIAL FUNCTIONS:

  • Serves as a primary Quality point of contact for one or more of Lundbeck's Contract Manufacturing Organizations (CMOs) and/or Contract Testing Laboratories (CTLs) and for the Quality oversight in alignment with regulatory GMP expectations and established Quality Agreements
  • Review and approve internal and external investigations, CAPAs, deviations, validation protocols and reports, change controls and vendor communications
  • Support Lundbeck's Product Complaint Investigations
  • Support internal lot disposition activities
  • Prepare applicable quality metrics for Quality Management Review meetings
  • Manage the Annual Product Quality Review Process
  • Collaborate with internal cross-functional teams including Manufacturing, Quality Control, Validation and Regulatory
  • Support and contribute to continuous improvements of the core quality systems
  • Comply with all company policies, procedures, work instructions and training requirements

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited bachelor's degree with a minimum of 6 years of experience in the pharmaceutical/biotech industry OR an accredited master's degree with a minimum of 4 years of experience in the pharmaceutical/biotech industry OR a combination of education and of experience in the pharmaceutical/biotech industry totaling 10 years
  • Strong understanding of multiple quality systems and adept at managing multiple priorities in a fast-paced, regulated environment
  • Ability to communicate effectively with internal personnel and Contract Manufacturing Organizations
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • The successful candidate will have 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 SAP, Microsoft Office Suite and Adobe Acrobat
  • Team player with the ability to work collaboratively with other functions to execute Quality System requirements
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited bachelor's degree in Sciences / Life Sciences
  • Experience with commercial biologics manufacturing
  • Experience working with CMOs and/or CTLs

TRAVEL

  • Potential for travel to international CMOs

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Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .

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 .

Job Summary

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Seattle, WA, United States Location
Full Time Job Type
Lundbeck

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