Engineering Quality & Compliance Specialist

Engineering Quality & Compliance Specialist

About Vifor Pharma:

Vifor Pharma, a company of the CSL Group, is a globally active pharmaceutical company focusing on innovative therapies in the areas of iron deficiency, nephrology, and rare diseases. In a highly regulated GMP environment, Vifor Pharma sets the highest standards in quality, compliance, patient safety, and continuous improvement. The Engineering Quality & Compliance team contributes significantly to ensuring inspection readiness, continuously optimizing processes, and supporting the reliable supply of patients worldwide.

Your Task:

As an Engineering Quality & Compliance Specialist, you are responsible for the coordination and implementation of quality and compliance activities within the engineering department. You drive change control processes, deviation management, CAPAs, and risk assessments, and together with various specialist departments, you ensure GMP compliance and permanent inspection readiness.

Your Responsibilities

• Control and coordination of change control processes in the engineering environment
• Creation, processing, and tracking of change requests (Change Controls)
• Ensuring the timely processing and closure of deviations, CAPAs, complaints, and associated measures
• Execution and moderation of risk assessments and Root Cause Analyses
• Implementation and tracking of improvement measures
• Creation and maintenance of entries in quality systems
• Analysis and reporting of relevant quality and compliance key figures
• Close cooperation with Quality Assurance, Quality Control, EHS, Regulatory Affairs, Metrology, and R&D
• Support in qualification projects and technical changes
• Preparation, accompaniment, and representation of the specialist department during GMP inspections and audits
• Ensuring continuous inspection readiness and compliance with regulatory requirements

Success Factors

• No overdue actions, deviations, CAPAs, complaints, or Change Controls
• Timely execution of investigations and risk assessments
• Sustainable implementation of effective Corrective and Preventive Actions (CAPAs)
• High GMP compliance and permanent inspection readiness
• Successful implementation of quality and process improvement initiatives

Your Profile:

Education & Professional Experience

• Bachelor's degree in Chemistry, Chemical Engineering, Process Engineering, or a comparable field of study
• At least 4 years of professional experience in a regulated production environment
• Experience in change management, deviation management, CAPA management, and GMP compliance

Technical Competencies

• Sound knowledge of GMP requirements and quality management systems
• Experience with risk assessments, Root Cause Analyses, and continuous improvement
• Knowledge of technical media such as water, purified water, steam, pure steam, and compressed air
• Proficient use of MS Office and QMS tools, ideally Veeva
• Business fluent German and English skills, both written and spoken

Desirable Additional Qualifications

• Further training in the field of Operational Excellence, Lean Management, or Six Sigma (Green Belt, Black Belt, etc.)
• Experience with GMP audits and regulatory inspections

Personal Competencies

• Analytical and structured thinking skills
• Strong problem-solving competence
• High level of initiative and sense of responsibility
• Strong communication and coordination skills
• Team-oriented way of working and cross-departmental collaboration
• Flexibility and high level of commitment
• Continuous improvement and quality orientation

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.