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.

PREFERREDEDUCATION, 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.