Product Quality Lead (Associate Director)

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 Late-Stage Development and Production groups. 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:
The Product Quality Lead (PQL) will provide technical expertise and project leadership to the Quality organization and will engage as product quality expert with Regulatory, Process and Analytical Development, Commercial and other departments for a variety of activities with one or more products. The PQL provides oversight for quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency/regional/local guidelines.  The PQL will act as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle.

ESSENTIAL FUNCTIONS:

• Provides cross-functional quality leadership and supports program deliverables for a commercial product and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network
• Provides quality perspective, expertise, and decisions as Quality representative on product cross-functional teams
• Key contributor to the annual product review 
• Provides guidance and Quality input to the CQAs, specifications, comparability, and stability programs Supports site and method transfers 
• Provides guidance to other QA representatives on teams with regards to product quality
• Authors and reviews sections of product regulatory filings Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels
• Recognizes key product quality risks (including weak signals and potential blind spots) and ensures timely escalation of the identified risks to the right levels of the organization
• Provides technical expertise and recommendations relating to product quality and influence global solutions to ensure continuous drug supply to patients.
• Ensures alignment of product changes and collaborates with key colleagues to develop bundling strategies that maintain global supply while improving product robustness
• Supports science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues.  

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor's degree with a minimum of 12+ years of experience OR Master's degree with 7+ years of experience, OR PhD. with 5+ of experience in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment 
• Experience working in a regulated environment (either direct GMP or technical role supporting GMP) 
• Demonstrated technical aptitude and experience with biologic drug development, analytical methods and commercialization 
• Proven leadership ability to manage challenging decisions in a logical and compliance manner, with a demonstrated ability to influence team members in a cross-functional environment and effectively communicate with senior management
• Skilled at guiding technically oriented business objectives within the framework of regulatory requirements and within internal and external quality systems
• 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

• Experience with authoring or review of market applications, IND, supplements or similar regulatory documentation 
• Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances 
• Demonstrated understanding of analytical method development, qualification/validation, and method transfer activities
• Experience in Project Management in support of pharmaceutical development 
• General knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals 
• Experience working on a cross-functional team in a matrix environment
• Action oriented and ability to manage time-dependent deliverables

TRAVEL

• Willingness/Ability to travel up to 20% domestically. International travel may be required. (If applicable)

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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.