QA Manager GCP and GVP Compliance

at  Ferring Pharmaceuticals Inc

Job Description:
Ferring+You
If you are looking for a job where you can unfold the full palette of your knowledge within Good Clinical Practice & Good Pharmacovigilance Practice this is the right job for you. In Ferring you will join a successful, global market leader and work with a broad and exciting product portfolio – and you will do it together with highly skilled colleagues in a well-functioning team.
Your day at Ferring

Your primary focus is optimization of our clinical and pharmacovigilance processes in collaboration with stakeholders such as compliance functions within the Clinical Development, Regulatory Affairs and Pharmacovigilance business areas. By focusing on continuous improvement, advisory and compliance support you will have ample opportunities to influence our way forward. Your primary tasks will be to:

• Participate and support quality improvement projects including reviewing procedures related to areas such as clinical operations, PV system, regulatory affairs and discovery including non-clinical development.
• Support and facilitate implementation of quality aspects in Ferring processes
• Support the assessments of quality risks covered by the supported stakeholder areas including implementation of mitigating actions
• Lead and support quality harmonization both locally and globally across Ferring Clinical Development sites along with compliance related to the use of computerised systems
• Contribute to the follow up on clinical and pharmacovigilance audit observations and deviations together with trending of observations and CAPAs
• Prepare relevant quality training programs and act as trainer
• Participate in preparation for and coordination during and after Regulatory Inspections
• Develop and maintain departmental quality metrics
• Write and update relevant SOPs owned by the department

Behind our innovation…There’s you

We are looking for a profile with knowledge, experience and drive to take on a role as outgoing support and enabler for the business. You must bring:

• At least 4+ years’ experience with clinical and/or pharmacovigilance activities/processes.
• An insight and understanding of important quality processes such as deviation, audit and inspection management as well as management review.
• Extensive stakeholder management skills
• Previous experience from working in a compliance or QA role is a preference but not a prerequisite for applying.
• Experience in working cross-organizationally and ability to create sustainable relationships – across cultural, professional and geographical borders.
• Very good communication skills
• Fluent English, written and spoken

People come first at Ferring
You will join a global team with 11 competent and dedicated colleagues which are responsible for the overall quality assurance of Ferring’s Global R&D, Marketing and Sales and Pharmacovigilance activities. The working atmosphere is characterized by respect, helpfulness and a shared passion for improving life for our patients.
Your new workplace is our spectacular and state-of-the-art new domicile “SoundPort”, an architectural landmark on the coast next to “Den Blå Planet”, minutes from Copenhagen Airport.
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.
If our mission and your vision are aligned, please apply!
Behind our purpose… There’s you
Contact and application
For additional information, please contact Head of Global Clinical Quality Caroline Sandström on +452878 7211. Your CV in English should be sent as soon as possible as we review applications on an on-going basis.
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at ferring.com
Location:
Ferring Denmar

Your primary focus is optimization of our clinical and pharmacovigilance processes in collaboration with stakeholders such as compliance functions within the Clinical Development, Regulatory Affairs and Pharmacovigilance business areas. By focusing on continuous improvement, advisory and compliance support you will have ample opportunities to influence our way forward. Your primary tasks will be to:

• Participate and support quality improvement projects including reviewing procedures related to areas such as clinical operations, PV system, regulatory affairs and discovery including non-clinical development.
• Support and facilitate implementation of quality aspects in Ferring processes
• Support the assessments of quality risks covered by the supported stakeholder areas including implementation of mitigating actions
• Lead and support quality harmonization both locally and globally across Ferring Clinical Development sites along with compliance related to the use of computerised systems
• Contribute to the follow up on clinical and pharmacovigilance audit observations and deviations together with trending of observations and CAPAs
• Prepare relevant quality training programs and act as trainer
• Participate in preparation for and coordination during and after Regulatory Inspections
• Develop and maintain departmental quality metrics
• Write and update relevant SOPs owned by the departmen

We are looking for a profile with knowledge, experience and drive to take on a role as outgoing support and enabler for the business. You must bring:

• At least 4+ years’ experience with clinical and/or pharmacovigilance activities/processes.
• An insight and understanding of important quality processes such as deviation, audit and inspection management as well as management review.
• Extensive stakeholder management skills
• Previous experience from working in a compliance or QA role is a preference but not a prerequisite for applying.
• Experience in working cross-organizationally and ability to create sustainable relationships – across cultural, professional and geographical borders.
• Very good communication skills
• Fluent English, written and spoke