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Feb 15, 2025

PV and GCP QA Quality Advisor - Remote Opportunity

Lundbeck LLC
Deerfield, IL, USA

Finance Health Care Information Technology Marketing Sales Neuroscience

Job Description

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 is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

Remote opportunity - Open to candidates in the United States, preferably East Coast or Midwest

POSITION SUMMARY:

The purpose of this position is to work within and support the R&D Quality Assurance Division in assuring compliance of established processes and procedures with relevant regulatory requirements and Lundbeck standards. To act as a lead auditor and independently manage assigned global audit activities, in line with the GCP and PV QA audit strategies and procedural framework. To provide R&D Quality oversight and support for pharmacovigilance and clinical trial activities and to support regulatory inspections, both in the US and globally.

ESSENTIAL FUNCTIONS:

Independently plan, conduct, and report complex PV and GCP audits, in accordance with approved annual audit schedule.
Provide unsupervised PV & GCP expertise and compliance advice to stakeholders in R&D, supporting the investigation and resolution of quality issue through close collaboration with internal stakeholders and vendors.
Lead the preparation, hosting and follow up of Regulatory Authority inspections related to GCP and PV activities at Lundbeck offices globally, as assigned.
Assist in the maintenance of audit and inspection processes, ensuring their suitability to support Lundbeck’s strategy and our value chain.
Support contract auditors as required, ensuring that findings from relevant audits reports are distributed, and responses and CAPAs are tracked and followed up as necessary in the CAPA system.
Deliver applicable regulatory training within the organization and at Investigator meetings, as needed.
Contribute to the maintenance of procedures and processes related to the respective area and the continual improvement of these processes to keep them up to date and in line with best practices and regulations.
Negotiate quality agreements with target vendors/CROs, monitor compliance with agreements and escalate when thresholds are crossed in accordance with escalation mechanisms.
Represent R&D Quality division with assigned special projects.
Provide input to the generation of R&D Quality metrics and trending information, interpretation, and recommendations.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

Accredited bachelor’s degree
8+ experience within the Pharmaceutical or Biotech industry, including 5+ experience GCP and PV, or relevant auditing experience within the pharmaceutical or Biotech industry.
Experience in leading projects and working within matrix organizations.
Strong understanding of applicable GCP/ PV regulations - ICH, FDA Code of Federal Regulations, European and international regulations.
Demonstrable organizational, analytical, and problem-solving skills.
Ability to work independently with minimal supervision, but also work effectively as part of a team.
Excellent written and oral communication skills with the ability to produce detailed audit reports and to professionally present thoughts and idea.
Maintain awareness of relevant legislation, regulatory requirements, and industry guidelines.
Ability to interact with and effectively influence personnel at all levels of the organization.

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

Accredited bachelor’s degree or accredited master’s degree in pharmacy, nursing, biology, chemistry, pharmacology, or related discipline.
Certified Quality Auditor (ASQ), Lead Auditor Certification (RQA), or RQAP-GCP (SQA) certification.
Experience with various international regulations, cultures, and markets.

TRAVEL:

Willingness/Ability to travel approximately 45% with some international travel required.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $180,000 - $210,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

Why Lundbeck

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 LLC

Lundbeck is a global biopharmaceutical company specialized in brain diseases. We are dedicated to advancing brain health and transforming lives. To fulfill this purpose, Lundbeck is engaged in the research, development, manufacturing, and commercialization of pharmaceuticals across the world. For more than 70 years, Lundbeck has been at the forefront of neuroscience research.

Our commitment is to empower patients to give them the tools and resources they need to understand their disease and its unfolding.
Our commitment is to continuously challenge status quo and push our science further to make real differences for patients.
Our commitment is to families to bring evidence-based data, visibility and support to their work in managing a chronic disease.
Our commitment is to communities to end the stigma, fear, and silence that surrounds brain diseases.
Our commitment is to society, to increase access to medicines for the most vulnerable, to act responsibly towards the environment and to behave with respect and integrity in everything we do.

Offices in:

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

We believe that if we build an inclusive, equity-focused organization, diversity will follow.

In simple terms, diversity is the mix. Inclusion is making the mix work. Equity is making sure we are fair and impartial in that process.

Diversity matters, and equity and inclusion create 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 DE&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 DE&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
401(k) match with immediate vesting
Non-Contributory 401(k) Employer Contribution
Parental Leave
Hybrid work model for office-based roles

To view more details about our Benefits, please go to the webpage below.

https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf

Our Sustainability Strategy

Through our sustainability strategy, we mitigate business risks, reduce negative impacts, and address societal challenges where possible. We remain committed to UN Global Compact Principles and contribute to seven of the 17 UN Sustainable Development Goals.

Lundbeck became a signatory to the UN Global Compact in 2009. We continue to promote initiatives that demonstrate our commitment to the 10 principles on human and labour rights, environment protection and anti-corruption.

Executive Management assesses Lundbeck’s business risks and opportunities and establishes our sustainability targets as communicated in our annual report.

We release an annual sustainability report describing in detail our sustainability performance and targets. For over a decade, we have reported on our sustainability efforts, challenges and contributions to our business, stakeholders and the societies we operate within.

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.