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Head of GCP& GVP Auditing

 
Requistion ID:  1310
Location: 

Copenhagen, N/A, DK

Date: 
 

Head GCP and GVP Auditing – R&D Quality

Lundbeck’s passion links to our purpose about restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.

 

Description

 

Are you an experienced and inspiring GCP and GVP Auditing manager looking for your next career step?  This is an opportunity for you to join a passionate team and help drive forwards Lundbecks GCP and GVP Quality Auditing activities. 

 

This role sits within our Research and Development area and is a key contributor in supporting our quality oversight activities for all clinical trials and marketed products. 

 

You will be leading a global team of highly qualified and experienced colleagues, working in an open, collegial and collaborative atmosphere where trust, agile and pro-active behaviors are essential.

 

This role is based at our Headquarters in Copenhagen, Denmark.

 

Your job and key responsibilities

 

This exciting role comes with the following responsibilities, where a proven track record of success will be required:

 

  • The development and implementation of a global risk based audit strategy for all GCP and GVP activities conducted by Lundbeck, its affiliates, partners, and vendors.
  • Providing leadership and direction to an Auditing team.
  • Define and deliver annual audit plan
  • Ensures that risk-based audits are implemented/resourced in a timely and effective manner and issues are adequately followed up
  • Escalate significant compliance issues to R&D Management
  • Accountable for the generation and presentation of audit quality metrics and trends for the business areas covered to contribute to the Quality Management Review process.  
  • Accountable for the establishment and maintenance of the QA-QA collaboration agreements and partnerships with Lundbeck business partners and strategic CROs
  • Accountable for the development and growth of employees within QA to ensure competencies and skills are continuously maintained to meet regulatory requirements and staff remain adequately trained to conduct their work with highest level of professional proficiency.
  • Travel up to 30% may be required

We offer

Lundbeck offers a great workplace that is based on a flat structure, forming a

collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.

 

Qualifications

 

Our preferred candidate has the following personal and professional qualifications:

 

  • University degree (or equivalent) in a scientific subject
  • 10+ years in quality assurance within the pharmaceutical industry in the areas of Good Clinical Practice and Good Pharmacovigilance Practice (external auditing qualification preferred)
  • Expert knowledge of both GCP and GVP
  • Knowledge of Risk Based Approaches / Quality Risk Management
  • Proven track record of effective leadership
  • Proven track record of engaging with internal stakeholders
  • Experience of management of external inspections
  • Strong collaborator and communicator in English, written and orally.

Further information

For further information, please contact Mike Britt on mibt@lundbeck.com or +45 30 83 20 97.  Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.

 

Your application

 

Please click on the apply button. Applications must be received no later than 31st October 2020.

 

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.