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Senior Manager, Quality Assurance and Compliance
hace 2 meses
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.
- 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.
