SCM Compliance Manager (Supply Chain/ QMS/ BioTech/ Pharma)
Duration: 6 Months Contract (Renewable / Convertible)
Salary : Up to $6000 depending on experience
Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.
Responsible for ensuring the company's adherence to regulatory standards and quality assurance within the supply chain function.
- Documentation and Recordkeeping: Oversee the creation and maintenance of accurate documentation for all supply chain activities. Ensure proper recordkeeping to demonstrate compliance with regulatory requirements by consulting the setup of new processes or the improvement of existing processes.
- Training and Education: Develop training programs for supply chain personnel to enhance awareness and understanding of compliance requirements. Provide ongoing education to the team regarding changes in regulations and industry best practices. Keep track of the training status withing the Supply Chain team.
- Risk Assessment: Identify and assess potential compliance risks within the supply chain and develop strategies to mitigate them.
- Audits and Inspections: Coordinate and participate in audits and inspections to verify compliance with regulatory requirements.
- Change Management: Oversee compliance aspects during changes in the supply chain, such as process modifications or system implementations. Drive the creation and implementation of Change Controls.
- Deviation management and CAPA: Oversee all the deviations to established procedures in supply chain management. Ensure effective CAPA are put in place and are executed as per agreed timelines.
- Ownership of transport verification: Identify the need of transport verifications and lead the corresponding activities
- Communication and Reporting: Communicate compliance requirements and updates to relevant stakeholders. Prepare and present regular compliance reports to management, highlighting key metrics and improvements.
- Cross-functional Collaboration: Collaborate with cross-functional teams, including quality assurance, regulatory affairs, and production, to ensure a unified approach to compliance.
- Emergency Preparedness: Develop and maintain contingency plans for supply chain disruptions, ensuring business continuity and compliance during unforeseen events.
- Solid understanding of SCM Compliance aspects, warehousing and logistics operations; ideally with 8+ years of relevant experience
- 5+ years of experience in the pharmaceutical or biotech industries
- Experience working in QMS / ERP / Transport Monitoring systems
- Should be comfortable operating in an dynamic environment and competing priorities.
- Undergraduate degree in Business, Science or Supply Chain disciplines
- Sense of ownership and honesty (proactive handling of errors)
- Great problem-solving skill and being able to work at start-up environment
Lim Pey Chyi (Apple) - Apple.email@example.com
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579