Senior Manager, Quality Assurance
Quality Assurance
Singapore
About us
At DHL, people mean the world to us. That’s why our goal has always been to attract and retain the best talent over the world. We provide challenge and opportunity for personal and professional development. We recognize the difference you bring to our business, and together we share the pride of building THE logistics company for the world.
Under the DHL Supply Chain umbrella, one of the business units of DHL, we provide customized logistics and industry solutions in the areas of supply chain management, warehousing, distribution, value added services, and lead logistics provider services for our customers – helping them deliver better results everyday.
Responsibilities
- Lead and manage the Quality Assurance Team, including Pharmacists.
- Oversee site quality management system and quality initiatives
- Oversee site regulatory permit, license, certification for pharmaceutical products and medical devices
- Perform audit on operational processes and ensure QMS compliance
- Lead customer audits on Quality Management Systems and other related topics
- Lead as Quality Representative in fulfilling the roles to support functional / Site Quality Management System. This also includes serving as customer contact on quality-related issues.
- Provide directions for developing, implementing and maintaining regulatory permit/ license to meet Health Science Authority requirement (GMP/ GDP/ ISO13485/ ISO9001)
- Managing the reporting of Deviations, CAPAs and Change Control
- Manage CSV Computer Systems Validation projects
- QRM ICH Q9 & ISO 13485
- Managing Validation Master Plans and Site Master Files in accordance with WHO and National GMPs
- Maintain links with appropriate professional bodies and licensing authorities
- Ensure pharmaceutical facilities are validated in accordance with regulations
- Create, review and approve SOPs/WIs/Standard forms for Life Science & Healthcare Operations
- Undertake various types of audits
Requirements
- Degree in any discipline
- 8 to 10 years of experience in similar capacity in Life Science or Pharmaceutical operations with at least 2 years of managerial experience
- Knowledge in Quality Assurance/In-process quality control and regulatory permit.
- Knowledge of cGMP/ISO9001/ISO13485 where applicable
- Excellent understanding and auditor of ISO Quality Management Systems and Regulatory Certification Systems requirement
- Professional affiliations (e.g. Lead Assessor for ISO13485/ ISO9001/ ISO18001/ ISO14001)
At DHL Supply Chain we take pride in our commitment to fostering a workplace that celebrates diversity and promotes inclusion for all. We believe that the diverse backgrounds, perspectives, and experiences of our employees are integral to our success. Our inclusive culture is built on the principles of equality, respect, and belonging, where every team member is valued and empowered.
We actively encourage individuals from all walks of life, regardless of age, race, gender, sexual orientation, religion, nationality, disability, or any other characteristic, to apply for positions with us. We are dedicated to providing equal opportunities, removing barriers, and creating an environment where everyone feels they truly belong.