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Quality and Compliance Manager (m/w/d), Wien

Created 01/28/2021
Reference 743999732783649
Category Compliance Officers
Job type Full Time
Country Austria
City Wien
Zip Not specified
Salary Competitive
Company Description

At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.

Every day, we seek inspiration from people living with atopic dermatitis. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.

As a purpose-driven company, high performance is measured equally as sales results and the positive impact we create ­- for health care professionals and their patients. These aspirations are encapsulated in our perpetual quest for the world's best talent.

Job Description

About this job

Working at Leo:

You will be part of a collaborative and innovative community of like-minded specialists connected by mutual respect; a caring culture; and our deep-rooted commitment to advancing the progress of biologic solutions within atopic dermatitis worldwide. Driven by dedication, ambition and agility, we apply our deep knowledge in dermatology and a focus on long-term results.

About your team:

You will join a highly motivated team - competing with the biggest pharmaceutical brands - inspiring one another with bold new ideas, expertise and knowledge to surpass our current size and reputation. With each step of the journey, you will see the impact of your contributions as we flourish and transform into a global leader in medical dermatology

Responsibilities:

• Ensure compliance and continuous improvement of the affiliate's Quality Management System, including but not limited to GDP and GPvP

• Manage the local Quality system, including the establishment, regular review and update of local quality documents

• Have an oversight about the company's compliance status by continuous KPI evaluation

• Provide regular update on the compliance status to the local management team

• Responsible for day-to-day product quality complaint management including case intake and follow-up activities in accordance with Global procedures and country regulations

• Act as local contact person for Competent Authorities and customers for product quality complaints

• Responsible for execution of local processes and activities in alignment with the Quality Management System, following department SOPs, company Policies and Procedures and country legislation

• Ensure compliant free medical sample handling and distribution

• Act in full compliance with global and local SOPs and manage any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues

• Support internal and external audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations

• Responsible for review and approval of all medical, sales and marketing activities requiring a (HCP-) compliance check in line with SOPs and local laws and requirements (AMG, Pharma VHC)

• Have an oversight about all regulatory activities for LEO's medicinal products with a Marketing Authorizations in Austria

• Training for all employees and relevant stakeholders including training documentation

Qualifications

• Master degree or equivalent experience in pharmacy, biology or equivalent.

• Several years of experience within GDP in the pharmaceutical industry

• Very good knowledge of the guidelines and requirements of the law in the healthcare system and pharma industry in Austria

• Detailed oriented, proactive, accurate, timely way of working

• Very good knowledge of German and English

• Excellent collaboration and communication skills

• Action oriented attitude

• Strong planning and aligning abilities

• Ensures Accountability

• Being resilient

• Optimizes work processes

Additional Information

Please note that we review applications and conduct interviews on an ongoing basis.