Senior Manager, Quality Operations

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Dec 17, 2020
Ref
1539
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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.

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of 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.

SUMMARY:

As part of a global team, manage Quality Systems (including Deviations, CAPA, Change Control, Product Complaints, Annual Product Review) in support of commercial biologics products. Primary responsibilities include managing quality interactions with contract manufacturers and laboratories, effectively managing exceptions, providing active support or lead role with investigations, assessing deviations/change controls, performing batch disposition, and ensuring compliance with applicable regulatory and industry standards for GMP manufacture of commercial 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:
  • Working with global colleagues, drives the implementation and optimization of quality management systems in support of commercial biologics products; assists in the authoring and review/approval of SOPs and applicable guidance procedures
  • Proactively identifies and promotes opportunities for continuous process improvements.
  • Serves as a primary Quality point of contact for one or more 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
  • Actively supports CMO campaign startup activities by performing and/or ensuring prompt and thorough review and approval of change controls and Master Batch Records
  • Serves as a Quality liaison with cross functional stakeholder groups to facilitate issue resolution in a compliant manner
  • 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
  • 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 / CTLs 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 activities related to biologic license applications and other regulatory filings, as required
  • Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities; overseeing professional development, and conducting performance reviews
  • Manages Quality Metric review process, assesses data for adverse trends, develops solutions and oversees implementation
  • Manages Product Complaints and Annual Product Review processes for commercial biologics products
  • Provides audit (internal/external) and inspection support, as needed


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 Biotechnology or Pharmaceutical Quality Assurance
  • In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements in commercial GMP operations
  • Excellent working knowledge of cGMP requirements, FDA /EMA regulations and ICH guidelines
  • 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


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
  • Accredited BS degree
  • Experience with commercial products
  • Familiarity with SAP for material control
  • Prior managerial experience (role will manage four independent contributors)
  • Experience with CMOs / CTLs and overseeing GMP operations


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


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.

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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.