Compliance Manager

2 weeks ago

Singapore DAIICHI SANKYO SINGAPORE PTE. LTD. Full time

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.

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