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Senior Quality Assurance cGMP Specialist

Employer
Lundbeck
Location
Wayne, NJ, United States
Start date
Jun 7, 2021

View more

Discipline
Clinical, Clinical Medicine, Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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 .

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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.

Company

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized 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. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

Offices in:

  • Deerfield, IL - Lundbeck US Home Office
  • LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
  • Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc

Diversity

Diversity matters, and inclusion creates powerful organizations

To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset.

Benefits

Lundbeck offers a competitive benefits package that includes:

• Medical, dental, vision effective day 1 of employment

• Generous vacation, sick leave, holiday shut down and company paid holidays

• 401k match with immediate vesting

• Parental Leave

• Hybrid work model for office-based roles

To view more details about our Benefits, please click on the link below.

Lundbeck 2023 Benefits Summary

Sustainable Development Goals

In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:

• Goal 3: Good Health and Well-being

• Goal 5: Gender Equality

• Goal 8: Decent Work and Economic Growth

• Goal 10: Reduced Inequalities

• Goal 12: Responsible Consumption and Production

• Goal 13: Climate Action

• Goal 16: Peace, Justice, and Strong Institutions

Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).

Lundbeck

Who We Are

A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.

What We Strive For

Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.

What Drives Us

A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.

Our Societal Commitment

We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.

Our Investment in You

As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.

Employee Satisfaction

The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.

Employee

Our Beliefs

• Patient-driven We put patients at the center of our fight for health and human dignity.

• Courageous We dare to confront unsolved healthcare challenges.

• Ambitious We set high expectations for ourselves because people in need have high expectations of us.

• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.

• Responsible We act with respect and integrity in everything we do

   

CONNECT

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Company info
Website
Phone
224-507-1000
Location
6 Parkway North
Deerfield
Illinois
60015
United States

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