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Head of Compliance Clinical Quality Assurance
hace 2 meses
About the Role
We are seeking a highly experienced and skilled Head of Compliance Clinical Quality Assurance to join our team at Innovative Medicines. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our clinical processes.
Key Responsibilities:
- Drive a culture of quality and excellence across our organization by forging strong partnerships with business stakeholders and implementing effective quality strategies.
- Collaborate with Quality System Owners and Business Process Owners to develop and implement robust strategies for clinical process changes, considering interdependencies and risk management.
- Prepare for audits by actively participating, supporting the formulation of a comprehensive CAPA plan, and ensuring its flawless implementation.
- Work closely with the Head of GCP Inspection Management and GCP Inspection Project Manager(s) to identify potential risk areas that may impact our processes.
- Guide Business Process Owners in preparing for specific presentations and deliverables requested during inspections.
- Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement and driving excellence through data-generated insights.
Requirements:
- Master's degree in life sciences, healthcare, or a related field, or an equivalent combination of education and experience.
- At least 10 years of experience in regulated activities, clinical development, and/or quality assurance in the pharmaceutical industry.
- Broad understanding of global expectations of Health Authorities in the area of Clinical Development and a profound understanding of the science of product development.
- High learning agility, mentally quick, comfortable with complexity and diversity, and highly interested in continuous improvement.
- Effective collaboration with stakeholders at all levels of the organization, with the ability to inspire and motivate cross-functional teams to drive change and promote a culture of excellence.
- Ability to present to senior management, corporate functions, and external audiences, including Health Authorities and government officials.
- Proficient English language skills.
