Senior Quality Assurance Manager, GCP
7 days ago
We are seeking a highly motivated and experienced Senior Quality Assurance Manager to join our GCP Quality team at Ascendis Pharma A/S. As a key member of our quality team, you will play a critical role in ensuring the compliance and quality of our clinical development and development operations.
Key Responsibilities- Collaborate with Internal and External Stakeholders: Work closely with internal teams and external partners to ensure the implementation and maintenance of GCP processes.
- Provide Expert Quality and Compliance Advice: Offer day-to-day guidance on GCP processes to clinical teams, ensuring adherence to regulatory requirements.
- Lead Subject Matter Experts: Oversee the maintenance of current SOPs and the development of new procedures, ensuring they meet GCP standards.
- Author and Maintain SOPs: Develop and maintain SOPs owned by GCP Quality, ensuring they are up-to-date and compliant with regulatory requirements.
- Support Regulatory Intelligence Monitoring: Assess the impact of new or updated GCP requirements on current practices and processes, and support implementation with relevant functions.
- Participate in Regulatory Inspections: Collaborate with subject matter experts to prepare for and respond to regulatory inspections, ensuring compliance with GCP standards.
- Support Quality Development Activities: Contribute to the development and implementation of quality management systems, ensuring they meet GCP requirements.
- Perform Expert Consultation: Provide guidance on complex GCP aspects to project teams and departments, ensuring compliance with regulatory requirements.
- Monitor Quality Systems: Proactively identify risks and implement corrective actions to ensure compliance with GCP standards.
- Support Clinical Trial Supply Team: Collaborate with the clinical trial supply team to ensure the design and operation of IRT systems meet GCP requirements.
To be successful in this role, you will need:
- A master's degree in a scientific discipline.
- A minimum of 5 years of relevant experience in the pharmaceutical industry, with significant experience in GCP from clinical quality and compliance.
- Extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
- Experience with computerized systems within GCP regulated areas and medical device experience would be an advantage.
- Proficiency in English at a professional level, both written and spoken.
Ascendis Pharma A/S is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
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