Johnson & Johnson
Commercial Quality Lead
Commercial Quality Lead
12months contract with high potential to renew
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining our client Johnson & Johnson
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Johnson & Johnson WORKSENSETM (via Randstad Sourceright) is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.
As an equal opportunity employer Johnson & Johnson value diversity at their company. They don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
DESCRIPTION
This role supports the Singapore Consumer Health, Medical Device and Pharmaceutical sectors to drive the management of Quality activities related to the registration, import, supply, distribution, and post-market surveillance of products in the Singapore market. The role is responsible to drive the timely management and execution of non-conformances, CAPAs, change controls, document and training, supplier management and key metrics related to these areas. This role will also lead audit readiness preparation and ensure compliance to applicable procedures and regulations.
In addition, this role is also responsible to plan, execute and drive the transformation of the Quality Management System for the Medical Device and Pharmaceutical sectors within Southeast Asia organisation.
RESPONSIBILITIES
- Quality & Compliance Responsibilities (Consumer Health, Medical Device and Pharmaceuticals)
- Ensure compliance of the Quality Management Systems against the company’s Quality policies and local regulatory requirements
- Drive timely management of Non-Conformances, CAPAs, Change Controls and Audit Actions as per timelines. Provides guidance to all involved with sufficient documentation, impact assessment and investigation. Monitors trends and implements actions to ensure timely completion
- Work closely with distribution center/distributors to ensure product inspection and release are conducted according to quality control program/specifications, including SAP system (as applicable).
- Quality & Compliance Responsibilities (Cross-Sector processes)
- Lead activities related to purchasing controls on the distributor management, which includes the oversight handling of storage, temperature control and batch traceability at the distributor sites, product release and returns and responsible for repack/relabel as applicable. Ensures indirect suppliers are appropriately qualified, monitored and in compliance to up-to-date Quality Agreements, where applicable.
- Lead on POLO management to ensure the POLO products and POLO suppliers are qualified, monitored and compliance to local regulations.
- Support the oversight and management of overall quality systems compliance for Singapore, including Management Reviews
- Ensures site compliance to Training Plan. Works with cross functions to ensure that trainings are available and executed on schedule.
- Ensures site compliance to Document Lifecycle Management. Ensures all GxP documentation are prepared, approved and subject to appropriate document control and retention as per site requirement.
- Transformation of Quality Management System
- Plan, execute and drive the transformation of the Quality Management System for the Medical Device and Pharmaceutical sectors within Southeast Asia organisation.
- Liaise with local, regional and global business partners to ensure timely implementation
- Audit Readiness
- Lead as site SME for audit management
- Ensure compliance and audit-readiness to J&J Quality Policy Standards and applicable procedures.
- Understand and ensure continued compliance to global and local regulatory requirements with respect to assigned responsibilities.
REQUIREMENTS
- Bachelor's degree or equivalent in Science, Data Science, Pharmacy or related discipline
- 5 to 7 years of experience in commercial quality within the medical device or pharmaceutical industry
- Understanding of Good Manufacturing Practice and Good Distribution Practice standards, industry and regulatory standards, end-to-end supply chain processes as well as the key elements of a quality organization
- Demonstrated ability to plan, execute and drive activities while managing multiple ongoing priorities
- People-influence and conflict-resolution skills
- Proficiency with Microsoft applications such as Excel, Word, Powerpoint, Data Analytics and tools
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button. Alternatively, you can share your CV at adam.shukri@randstadsourceright.com.sg
EA License: 94C3609
Reg No: R22104540