Senior Manager, Quality Assurance and Compliance

hace 5 días

Madrid, Madrid, España Sin Nombre A tiempo completo
Job Summary

Sin Nombre is seeking a highly skilled Senior Manager, Quality Assurance and Compliance to join our team. As a key member of our organization, you will play a critical role in ensuring the delivery of high-quality products and services while maintaining compliance with regulatory requirements.

Key Responsibilities
  • Conduct comprehensive investigations into deviations and incidents that occur within clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines and maintaining the integrity and quality of clinical trial data.
  • Collaborate with cross-functional teams to gather insights and expertise to facilitate root cause analysis and develop effective corrective and preventive actions (CAPAs).
  • Develop and implement CAPAs specific to clinical trials based on the findings of the investigation, ensuring alignment with GCP regulations, clinical trial protocols, and applicable regulatory requirements.
  • Monitor and track the effectiveness of implemented CAPAs and ensure their compliance with GCP guidelines and regulatory requirements.
  • Act as a primary contact for internal and external stakeholders, providing critical information, advice, and guidance on complex issues related to quality assurance and compliance.
  • Mentor and support the onboarding of new team members, fostering employee engagement, inclusion, and Credo Behaviours.
  • Define the required skills and capabilities for effective quality management and ensure appropriate training.
  • Lead initiatives and actively participate in key projects, interacting with key stakeholders and influencing project outcomes.
Qualifications
  • Bachelor's degree or equivalent in a relevant field, such as Life Sciences, Business Administration, or a related field.
  • Minimum of 6 years' experience in pharmaceutical, healthcare, or related industries, with a strong background in quality assurance and compliance.
  • Excellent knowledge of GCP guidelines, clinical trial regulations, and relevant regulatory requirements.
  • Experience in conducting investigations, root cause analysis, and CAPA development specifically focused on clinical trials.
  • Strong leadership and communication skills, with the ability to foster team productivity and cohesiveness.
  • Ability to manage complexity under pressure and make sound decisions.
  • Proven track record of investigation management and experience in transforming organizations in response to business needs.

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