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Senior Quality Assurance cGMP Specialist

 
Requisition ID:  1782
Location: 

Wayne, New Jersey, US

Date:  Apr 7, 2021
 

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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

 

SUMMARY
This position will provide support for release, and on-going maintenance of commercial product, and new product introduction. Additionally, this role will contribute to process improvements, harmonization projects between the DK, US, CAN sites as well as helping to ensure adherence to Regulatory regulations as defined by the FDA, EU, DEA etc. The incumbent will be responsible for conducting Product Quality Audits for Lundbeck vendors and partners globally.
 

ESSENTIAL FUNCTIONS

  • Conduct Internal and External Quality Assurance (GMP) Audits
  • Review and release of commercial product for the US market
  • Review and processing of deviations/investigations, change controls, analytical data, protocols, etc.
  • Process product quality and distribution complaints
  • Perform site gap analysis and define inspection readiness objectives
  • Monitor CAPAs at Contract Manufacturing Organizations (CMOs)
  • Review and revision of existing SOPs and creation of new SOPs as required
  • Maintain site metrics (KPI’s) on monthly basis tracking improvement
  • Management of department documentation room, and virtual files
  • Entry of data/information into various validated computer systems Open Text- D2 Documentum, Pluto, SAP
  • Participate in Lean Activities with team resulting in cycle time improvements
  • Conduct PQR’s for CMO’s and archive in SAP
  • Maintain and track new product launch activities with various Contract Organizations
  • Support and Lead special projects as defined
  • Represent the team during daily, weekly, monthly, quarterly CMO team meetings
  • Author and train on relevant SOPs related to the Global Quality System
  • Travel to CMO sites to facilitate investigations, inspections, and or qualifications and validations
  • Maintain up to date knowledge of US GMP requirements
     

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Master’s degree with 5 years of relevant Pharmaceutical experience or accredited bachelor’s degree with 7 years of relevant Pharmaceutical experience including:
  • Pharmaceutical Manufacturing/ Contract Manufacturing oversite environment
  • GMP compliance training
  • Familiarity with Supply Chain functions and interactions
  • Proficient in Excel, Microsoft Teams, & DocuSign
  • Basic knowledge of FDA guidelines and regulations
  • ISO 9001 Lead auditor certification or a willingness to be trained
  • Willingness/Ability to travel up to 30% domestically and internationally.
     

PREFERRED EDUCATION, EXPERIENCE AND SKILLS

  • Accredited Master’s degree in Pharmaceutical or related scientific field
  • Demonstrated ability to perform essential Quality Management System functions: Releases, GMP/GDP Investigations, Audits, Qualification /Validation, Artwork approval, Change Control, and process complaints of marketed products.
  • Proficient in writing and modification of SOP’s for the department
     

 

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.

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.