Principal Medical, Regulatory and Clinical Quality Assurance Advisor
No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The purpose of this position is: to work within and support the Medical Regulatory and Clinical Quality Assurance Division (MRC) 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 MRC QA audit strategies and procedural framework; and to provide relevant MRC QA oversight and support for clinical trial and inspection activities, both in the US and globally.
* Plans, conducts, reports and follows up on assigned routine and/or directed audits, in line with MRC QA steering documents including providing input to the audit schedules and preparing project audit plans.
* Acts as MRC QA lead in line with MRC QA steering documents, as assigned.
* Provides GCP/PV expertise and compliance advice in areas related to International Clinical Research (ICR) including Pharmacovigilance (PV) and Clinical Pharmacology, as applicable.
* Supports training of Auditors within MRC QA, in association with the Head of MRC QA. Provides ICH GCP and applicable regulatory training within the organization and at Investigator meetings, as needed.
* Supports and/or coordinates GCP and Pharmacovigilance Regulatory Authority inspections, as applicable.
* Contributes 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.
* Functions as MRC QA contact person for CRO and partner clinical quality collaborations.
* Represents MRC QA division with assigned special projects.
* Provides input to the generation of MRC QA metrics and trending information, interpretation and recommendations.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
* Accredited Bachelor’s degree
* 8+ experience within the Pharmaceutical or Biotech industry
* 6+ years Good Clinical Practice (GCP), or relevant auditing experience
* 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 ideas
* Ability to 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 or Master's degree in pharmacy, nursing, biology, chemistry, pharmacology, or related subject
* Certified Quality Auditor, Lead Auditor Certification or ISO certification
* Experience with various international regulations, cultures and markets
* Willingness/Ability to travel approximately 45% of time with some international travel required.