Total 4 job vacancies by Daiichi Sankyo Singapore Pte. Ltd.

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.

Overall job objectives

This position is responsible to:

• Collaborate with stakeholders within R&D PV QA, as well as outside of R&D PV QA, such as procurement, finance, legal (as applicable), R&D, Clinical Safety and Pharmacovigilance (CSPV), Medical Affairs, Market Access, Non-clinical Research, and IT to ensure consistent implementation of the GxP vendor quality program across Daiichi Sankyo group companies.
• Continuously assess existing practices and identify areas that need refinement and/or areas to archive a fit-for-purpose GxP vendor quality program in the Daiichi Sankyo group.
• Ensure that GxP vendor qualification status is current, periodically review the risk category of all existing GxP vendors, and prioritize them to be included in the Master Audit Schedule for the subsequent fiscal year.
• Collaborate with stakeholders within R&D PV QA, Legal, and business functions to ensure QA agreements are established for all critical GxP vendors.

Core responsibilities

• Vendor Qualification and Management
• Lead the qualification process for new GxP vendors, including Contract Research Organizations (CROs), Clinical Laboratories, GLP Laboratories, GxP IT computerized system/software vendors, Pharmacovigilance (PV) third parties, etc.
• Conduct risk-based assessments and evaluations of vendors to ensure compliance with regulatory requirements and internal company standards.
• Manage the approved global vendor list and ensure all vendors are qualified, approved, and monitored according to company policies.
• Vendor Audit and Inspection Support:
• Provide input from an audit focus area perspective to Audit & Compliance during the vendor audit planning stage.
• Act as a Subject Matter Expert (SME) for vendor quality and provide support to the inspection management team before, during, and after the audit and regulatory inspection.
• Compliance and Documentation
• Develop and maintain vendor-related quality agreements, ensuring clear roles and responsibilities for GxP compliance are established.
• Ensure proper documentation of all vendor quality activities, including qualification records, and risk assessments.
• Monitor vendor quality performance through Key Performance Indicators (KPIs) and Quality Metrics, providing regular reports to senior management.
• Cross-Functional Collaboration
• Collaborate with internal stakeholders, including business functions, procurement and legal to align on vendor quality requirement.
• Support the resolution of vendor-related issues that impact quality, data integrity and scientific integrity, timelines or compliance.
• Continuous Improvement
• Lead continuous improvement initiatives related to vendor quality management processes.
• Stay current with industry best practices, regulatory changes, and trends in GxP compliance, and implement changes to maintain an industry-leading vendor quality program.

Job Description:

Including but not limited to:

• Regulatory dossier review and submission
• Liaison with internal and external regulatory stakeholders
• Provide strategic input on regulatory strategirs to achieve acceleration
• Handles all regulatory aspects

Job Requirement:

• Experience in Singapore Regulatory Agency submission, Biologics submission
• Knowledge in GMP/QA/AE process
• Only open for part-time vacancy.

Job Description:

• Coordinate and assits to book air ticket & hotel for the stakeholders
• Coordinate and assits the stakeholders to claim their expenses.
• Coordinate and make the events arrangement
• Others admin support if required.

Requirements:

• Meticulous and well-organised, able to work independently.
• Minimum Education Level: GCE ‘O’/’N’ Levels/Nitec.
• Proficiency in MS Office, especially MS Excel.
• Able to work 16 hours or 2 days a week.
• Hybric work arrangement