Senior Manager Quality Operations - Biologics Commercial Quality Systems

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
Primary responsibilities include managing contract manufacturing projects for the QA unit, effectively managing exceptions, providing active support or lead role with investigations, assessing deviations/change controls, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products. As Senior Manager, this role is expected to effectively lead and guide a team of QA staff and effectively partner with cross-functional teams.

ESSENTIAL FUNCTIONS

• Serves as a primary Quality point of contact for one or more Lu-SBP’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
• Serves as a Quality liaison with cross functional stakeholder groups to facilitate issue resolution in a compliant manner
• Serves as team leader in quality investigations and ensures corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented
• Reviews, assesses and approves non-conformance reports, including deviations, laboratory / OOS investigations originated at Lu-SBP’s CMOs / CTLs, as well as the deviations and investigations originated internally
• Drives for prompt escalation and works closely with subject matter experts (SMEs) and CMOs to identify the root cause and implement corrective actions or preventive actions (CAPA) and assess their effectiveness
• Reviews, assesses and approves internal and vendor related change controls
• Supports the activities related to biologic license application and other regulatory filings, as required
• Actively plays a lead role in the development and maintenance of the overall Lu-SBP quality management system in support Lu-SBP commercial products; assists in the authoring and review/approval of SOPs and applicable policies
• Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities;
• overseeing professional development, and conducting performance reviews
• Participates in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation
• Proactively identifies opportunities to strengthen the quality processes and recommends appropriate changes Provides audit (internal/external) and inspection support, as needed
• May support CMO campaign startup activities by performing and/or ensuring prompt and thorough review  and approval of change controls and Master Batch Records
• May direct batch record review and perform lot disposition activities, to ensure disposition of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• Accredited Bachelor’s degree with 8+ years’ relevant experience in Biotechnology or Pharmaceutical Quality Assurance or a combination of education and experience totaling 12 years’ experience
• In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements in clinical and commercial GMP operations
• Excellent working knowledge of cGMP requirements, FDA /EMA regulations and ICH guidelines
• Experience with CMOs / CTLs and overseeing GMP operations
• Understanding of regulated biotechnology processing
• Ability to couple technical process understanding with a strong regulatory and compliance understanding to ensure that operations are conducted in an efficient, and above all, compliant manner to deliver safe and effective therapies to our patients
• Excellent written and oral communication skills and the ability to proactively prioritize and accomplish multiple tasks simultaneously
• Strong analytical and problem-solving skills
• Ability to work independently, and cross-functionally, and develop/maintain strong partner relationships both, internal and externally
• Ability to influence teams and to balance scientific judgment and compliance to cGMP when a risk-based approach is appropriate
• 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, EXPEREINCE AND SKILLS

• Experience with clinical and commercial products is preferred
• Familiarity with SAP for material control
• Prior managerial experience

TRAVEL

• Willingness/Ability to travel up to 10% domestically. International travel may be required

#LI-LM1, #LI-Hybrid

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.