The Ethics and Compliance Manager ensures that the business practices of Daiichi Sankyo Singapore Pte Ltd adhere to ethical standards and pharma codes. This role is pivotal in maintaining a robust Quality Management System (QMS) to oversee and promote compliance with industry standards. The manager fosters a culture of compliance across the organization by collaborating with cross-functional teams.
Quality Management System
· Lead the ethics compliance and pharma code quality functional area within the QMS.
· Oversee the development, implementation, and maintenance of the QMS.
· Ensure processes, procedures, and documentation comply with quality standards.
· Act as a document controller for all QMS documentation.
· Coordinate and track the creation, review, and update of all quality documentation, including policies, procedures, templates, and forms.
· Support the identification of opportunities for improvement and manage continuous improvement activities.
· Maintain registers related to organizational and quality activities, including quality documentation, change control, deviations, CAPAs, and vendors.
· Collaborate with functional heads to create and revise company policies and SOPs.
Risk Management
· Regularly assess and monitor risk factors to prevent non-compliance.
· Drive service and quality standards by ensuring staff accurately follow quality management systems.
· Create an annual audit schedule covering internal and external stakeholders.
· Complete self-assessments and conduct regular internal audits in line with the annual audit schedule.
Compliance
· Act as the privacy officer, contributing to agreements with respect to privacy wording.
· Stay updated on industry regulations, guidelines, and standards.
· Plan and conduct compliance training to promote ethics and compliance.
· Implement, manage, and review role-based training curricula with line managers and department heads.
· Assign role-based training curricula to staff members as agreed with line managers and department heads.
· Serve as the key user for the Learning Management System (LMS) to ensure staff are trained according to their assigned curricula.
· Ensure regular review of quality documentation to maintain compliance with applicable regulations, guidelines, and standards.
· Oversee and manage the implementation of Corrective Actions and Preventative Actions.
· Oversee product complaint registers and investigate high-risk incidents and adverse feedback.
· Prepare for and participate in external audits, quality reviews, and accreditations.
· Facilitate and document internal compliance meetings.
Culture of Compliance
· Develop regular reporting mechanisms for internal departments and leadership teams to monitor compliance.
· Provide feedback on risks and identify trends and improvements to leadership teams and department heads.
· Support employees in implementing quality requirements.
· Establish reporting channels as required.
