(Senior) Compliance and Quality Manager

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(Senior) Compliance and Quality Manager

Vifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization and optimization. As such a newly created vacancy has been created in the Swiss Affiliate of Vifor Pharma based in Villars-sur-Glâne or Fribourg for a compliance and quality (senior) manager to focus on swiss medical compliance, quality and (in case of business need) pharmacovigilance topics.

You will ideally have a background in medical or healthcare compliance for the Swiss pharmaceutical market (PK/PKK, VITH, ABAC, Legal, Data Privacy etc) and have a fluency in one of German or French plus working proficiency of the other languages plus English.

Roles And Responsibilities

Compliance & Quality Management (QCM) (Primary focus)

• Local Responsible Person for Medical Compliance (PK/PKK, ABAC, VITH, Legal, Data Privacy), except for promotional materials.
• Setting up, maintaining and supervising a quality and compliance system for VPCH, in accordance with applicable GXP guidelines, Pharma Codices and ABAC policies in close alignment with peers.
• Preparation/running of audits and inspections.
• Regular reporting to line manager and special duties on assignment.
• Liaises tightly with Quality Manager and Head Medical to oversee and manage local and global QC activities.
• Organizes regular QCM-Update meetings with QCM staff.
• Liaises regularly with Legal Counsellor to discuss VPCH legal issues.
• Prepares together with Quality Manager for audits and inspections in Switzerland and develop CAPA in response to findings.
• Coordinates contract management activities within VPCH and between departments and provides contracting tools to VPCH staff.
• Supports and offers necessary trainings to VPCH departments regarding compliance issues (PK/PKK, ABAC, VITH, Data Privacy; Legal).
• Supports and approves local and cross-country ABAC-related activities (e.g. sponsorship and engagement requests).
  
  

Pharmacovigilance (Supporting focus)

• Coordinating drug safety contract management for Switzerland and foreign countries (where applicable).
• Maintaining a GVP quality system compliant to applicable national and international regulations and guidelines (e.g. case processing, training, contracting, interfacing, documenting, etc.).
• Maintaining audit readiness for GxP audits and inspections.
• Good communication with EU-QPPV office, enabling EU-QPPV to have sufficient oversight of the PV-VIF system.
• May perform where necessary the safety data processing activities by the PV-VIF team and organizes regular PV-Update meetings with PV-VIF team.
• Liaises with Vifor departments, consultants and external service providers for collection and management of safety data.
• Initiates, coordinates and negotiates SDEAs for in-licensed products in Switzerland.
• Supports authorship of aggregate and risk management reports for VIF products where necessary.
• Supports maintenance of PV-relevant local procedural documentation and compliance with global SOPs.
• Supports PV-team in signal- and risk-management activities.
  
  

Qualifications

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

• University degree in medicine, pharmacy, pharmacology or life science
• Experience in Swiss Healthcare/Medical compliance activities and in the respective legal framework
• Ability to communicate clearly and logically
• Ability to manage and motivate people
• Fluency in local languages (German or French), with working knowledge of the other, and English
• Some years experience in pharmaceutical industry or in equivalent positions of competent authorities
• Skilled user of Microsoft Office (Word, Excel, PowerPoint, Outlook) and Windows
  
  

Preferred Requirements

• MD, PhD or M. Sc. level
• Knowledge of GVP principles and guidelines.
• Experience in Compliance and Quality Management principles.
• People and/or project management skills.
  
  

About Us

At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.

Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career .

What You Can Expect Of Us

As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.

Including:

• Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
• Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
• Flexible workplace environment, home office opportunities, competitive vacation entitlement
• Attractive financial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans

Join Vifor Pharma Talent Community

If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community .

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