Location: Switzerland - Glattbrugg/Zurich
Function: Quality Management
Company: Vifor Pharma
In this strategic position, supporting our global quality organization, we are seeking a Head of Clinical Quality Management. You will be responsible to manage a team, implement processes related to the Vifor Pharma quality management goals and support with the development of clinical and regulatory strategies. Reporting directly to the Head of Global Quality Management, your tasks and responsibilities will include, but not be limited to, the following:
- Manage staff respecting internal and external regulations and requirements
- Establish and coordinate all audit programs for Quality Management (QM) Clinical, Medical and Regulatory
- Provide Clinical Quality Assurance (CQA) expert input to business and projects
- Ensure inspection readiness for Vifor Pharma organisations under CMR surveillance responsibility
- Provide input, support and surveillance of Pharmacovigilance organisation/s within Vifor Pharma
- Assure adequate CAPA management overview
- Follow up and input into the organisation of guidance development
- Assure CQA input in clinical development programs as well as timely audits of study sites and databases (GCP audits)
- Support and survey affiliates in Agency Inspection preparation, management and subsequent CAPA implementation
- Preparation, hosting and follow-up of Agency Inspections
- Assures qualification of third party service providers
- Track expenditures against approved budgets and establish plans within the planning cycles
- Maintain procedural documents system and respective processes
- Ensure adequate training status of CMR departments
- Provide input into Corporate Quality Systems (Quality Risk Management, KPI etc.)
- Ensure harmonisation of processes/PDs across locations & with QM GMP
The ideal candidate holds a university degree in life sciences field in addition to the following experience:
- 5 – 10 years’ experience successful leading a Clinical Quality organisation, including managerial experience
- GCP & PV experience in the pharmaceutical industry
- Extensive understanding of interpretation for FDA, EU and ICH regulations (GCP, PV)
- Demonstrated ability to develop, implement, maintain and improve quality organisations and procedures
- Demonstrated ability to lead successfully different cultures
- Successful collaboration with functions in the clinical, regulatory and quality area
- Mandatory language skills in English and preferably German
- Ability to use IT support systems in the office and QM – related area
You have excellent leadership, management and organisation skills. You have a compliance and solution driven style of communication and interaction with relevant stakeholders. You are able to work successfully independently and within a cross-functional environment. You practice high ethical standards, integrity and are able to maintain confidentiality. You are able to translate non-compliance into risk assessment. You effectively apply professional judgement on risks. You are precise in your working style. You work in line with the Vifor Pharma values.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.