Quality Assurance GCP Manager (m/w/d)

Falk Pharma Australia Pty; Freiburg im Breisgau; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Free beverages

Health and sports benefits

Canteen

JobRad

Comprehensive onboarding and mentoring

Diverse learning culture

Job summary

Falk Pharma Australia Pty in Freiburg im Breisgau, Germany, seeks a Quality Assurance (QA) GCP Manager to lead the quality management framework in line with GCP and ICH-GCP guidelines.

You will audit sites, support regulatory inspections, maintain SOPs, manage CAPAs, train staff, and report metrics to senior management while collaborating with internal teams and external partners.

Qualifications

• Several years of experience in GCP quality assurance or related fields within the pharmaceutical industry or a Health Authority.
• Experience in planning and conducting GCP audits.
• Degree in Life Sciences, Pharmacy or a related field.
• Extensive knowledge of GCP guidelines, ICH-GCP standards, and global regulatory frameworks (EMA, FDA, MHRA, etc.).
• Strong understanding of clinical trial methodologies and quality management systems.
• Ability to work independently, build stakeholder relationships and provide pragmatic quality guidance in a dynamic clinical development environment.
• Exposure to CSV activities and oversight from a QA perspective would be advantageous but is not essential.
• Excellent written and verbal communication skills in both German and English (C1 or above).

Responsibilities

• Audit, Inspection, and Deviation Management: Plan and conduct GCP audits across sites, vendors and internal processes.
• Regulatory readiness: Support regulatory inspections and contribute to maintaining inspection readiness.
• CAPA: Oversee CAPA specific to GCP (internal or external).
• Quality Assurance and Compliance: Create and update SOPs, policies, and checklists to ensure GCP compliance.
• Risk Management: Implement risk mitigation strategies at all levels.
• Training: Develop and implement training programs on GCP and QA principles.
• Documentation and Reporting: Analyze and present quality metrics and audit findings to senior management.

Skills

GCP quality assurance

GCP audits

Regulatory frameworks EMA/FDA/MHRA

Clinical trial methodologies

Stakeholder management

CSV knowledge

Bilingual German/English

Education

Life Sciences or Pharmacy degree

Job description

As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for:

Your tasks

As the \"Quality Assurance (QA) GCP Manager\"“ within the GCP and GVP Quality Department, you will play a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Clinical Practice (GCP) guidelines. Collaborating closely with internal teams and external partners, you will ensure regulatory compliance and promote a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to:

Audit, Inspection, and Deviation Management

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Support the preparation and management of regulatory inspections and contribute to maintaining inspection readiness
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Quality Assurance and Compliance

• Create and regularly update quality standard operating procedures (SOPs), policies, and checklists to ensure compliance with current GCP standards

Risk Management

• Implement Risk Mitigation Strategies at all levels

Training and Knowledge Development

• Develop and implement targeted training programs on GCP and quality assurance principles to ensure staff proficiency and compliance

Documentation and Reporting

• Analyse and present quality metrics and audit findings to senior management to support decision-making

Your qualification

• Several years of experience in GCP quality assurance or related fields within the pharmaceutical industry or a Health Authority
• Experience in planning and conducting GCP audits
• Degree in Life Sciences, Pharmacy or a related field
• Extensive knowledge of GCP guidelines, ICH-GCP standards, and global regulatory frameworks (e.g., EMA, FDA, MHRA, etc.)
• Strong understanding of clinical trial methodologies and quality management systems
• Ability to work independently, build strong stakeholder relationships, and provide pragmatic quality guidance in a dynamic clinical development environment.
• Exposure to computerized system validation (CSV) activities and oversight from a QA perspective would be advantageous but is not essential
• Excellent written and verbal communication skills in both German and English (C1 or above)

Your Benefits

• Supportive, respectful and appreciative work atmosphere in a small, dedicated team
• Diverse learning culture and individual development opportunities
• International and growing family business with short decision-making processes, financial independence and long-term perspective
• New work, flexible working hours and mobile working
• Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
• Comprehensive onboarding and mentoring program