Head of Quality Assurance Operations - Geneva

Location: Switzerland - Meyrin/Geneva

Function: Quality Management

Company: OM Pharma

Marilda Martins

Senior Talent Acquisition Specialist

+41 58 851 67 69

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About You

In this challenging position, you are responsible for the Quality Assurance Operations (QA Ops) Team for our Biotech Production Site in Geneva. You report directly to the Head of Quality Management and are in charge of a team of 6 people. Your main role is to contribute on Geneva Site business delivery by ensuring QA Ops routine activities and guarantee the quality of manufactured products. As a key interface of Geneva Site, you manage and ensure successful collaboration with all stakeholders within and outside Quality Management Department. Your main responsibilities include:
  • Ensure the business delivery of Geneva Site products of the required Quality by respecting Company Quality Standards
  • Manage a team of QA Specialists dedicated to different business activities (Biotech & Pharmaceutical Manufacturing, Quality Control, Engineering activities). Ensure that roles and responsibilities of each team members are well defined and understood within and beyond QA Ops team
  • Ensure that production and quality control batch records are reviewed, that products are released on time according to specifications, SOPs and Quality Systems in place
  • Schedule and organize resources to ensure adequate coverage for on-the-floor QA Ops activities
  • Control that deviations are consistently filled, reviewed and closed on time within QA Ops activities, Manufacturing, Engineering and Quality control laboratories. Act as a leader to manage root cause analysis and solve complex issues
  • Ensure that CAPA and change Control related to QA Ops activities are correctly managed while respecting timelines targets
  • Manage the impact assessment, quality approval and follow-up of change control records and actions
  • Manage the timely review of facility and utility monitoring records and support data to assure completeness, traceability, accuracy, and compliance to cGMP requirements
  • Interact with cross functional groups to resolve discrepancies/observations discovered during lot review
  • Review and approve qualification and validation reports, as well as procedures and specifications impacting on the identity, purity and quality of final products for approval or rejection
  • Provide review and input for generation of new or revised SOPs, Master Batch Records and other controlled documentation
  • Ensure data readiness and review of Product Quality Reviews (PQRs). Review report findings and make recommendations for corrective and preventive action
  • Ensure quality review and approval of stability protocol and reports
We are looking for an accurate and solution-oriented person with the following profile:
  • University Degree in Pharmacy, Chemistry or Biology
  • 5 to 10 years of professional experience in a Quality Assurance role within pharmaceutical industry
  • Proven experience in people management
  • Experience in a Biotech company and Quality Operation role is an asset
  • English and in French both in oral and written conversation
You are a well-organized and entrepreneur person, who likes to work in a very autonomous and rigorous way. You hold very good communication and organization skills that enable you to work efficiently in cross-functional teams and to properly deal with organization’s stakeholders. Thanks to your analytical thinking, you understand issues from multiple perspectives and see inter-relationships and cause-and-effect relationship. You are a proactive person with leadership, who likes to suggest possible improvements.

About Us

Vifor Pharma Group, formerly Galenica Group, is a global pharmaceutical 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 consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma. With its unique expertise in the field of immunology, OM Pharma develops and manufactures infectious diseases/OTX products for respiratory tract infections, lower urinary tract infections, ear care, abdominal distension, chronic obstructive pulmonary disease, chronic venous insufficiency, diabetic retinopathy, haemorrhoids, menometrorrhagia (heavy menstrual bleeding).

For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.

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