PV and GCP QA Quality Advisor

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!

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 manage assigned global audit activities, in line with the GCP QA audit strategies and procedural framework. To provide relevant R&D Quality oversight and support for clinical trial, Pharmacovigilance and inspection activities, both in the US and globally.

ESSENTIAL FUNCTIONS:

• Plan/Manage, conduct, report and follow up on insourced or outsourced GCP and PV audits, in line with R&D Quality steering documents.
• Provide unsupervised GCP/GcLP/PV expertise as applicable and compliance advice in areas related to International Clinical Research and support the resolution of quality issues.
• Support the development of the GCP/GcLP/PV annual audit schedule and project audit plans adopting risk-based approaches
• Deliver GCP/PV and applicable regulatory training within the organization and at Investigator meetings, as needed
• Support and/or coordinate GCP and PV Regulatory Authority inspections, as applicable
• 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
• Function as R&D Quality key contact for CRO and partner clinical quality collaborations
• Provide input to the generation of R&D Quality metrics and trending information, interpretation, and recommendations

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

• Bachelor's degree in Life Sciences or related discipline
• 8+ experience within the Pharmaceutical or Biotech industry
• 5+ years GCP or PV auditing experience
• Experience in leading projects and working within matrix organizations
• Strong understanding of applicable GCP or 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

PREFERREDEDUCATION, EXPERIENCE, and SKILLS:

• Master's degree in pharmacy, nursing, biology, chemistry, pharmacology, or related subject
• 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 specifically for those potential hires who will work or reside in the state of Illinois, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $180,000,000 - $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-BK1

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. 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.