Senior Manager Apac Self-care Franchise Quality

3 days ago


Singapore Johnson & Johnson Family of Companies Full time

The Self Care Franchise Quality Associate Director/Snr Manager supports and drives the Franchise Quality Strategy to ensure compliance to regulatory, J&J & Consumer Health requirements in support of the regional business needs by incorporating input from the Consumer Health Supply Chain Strategy, Franchise Strategy, and regional business needs. The role will identify changes needed to the quality systems, processes, and organization to support the global and regional business strategy in coordination with local and regional quality leaders.

The role will be the primary contact for the Franchise business partners and Global Franchise Quality community and will be a member of the Self Care supply chain working teams, proactively identifies and mitigates risks associated with business activities. The role will co-create governance framework with the Regional Heads of Quality to ensure a constant understanding of changing business needs and knowledge transfer and harmonization across the regions. This includes coordination to adapt market connections for lead market innovation as well as supporting the adapt market where needed. Specifically multi-market product quality issues and escalations and act as the Quality representative for multi-market QRBs.

Support immediate issue resolution and provide quality direction for continuous improvement of established products, support new acquisitions and exit strategies for divestitures. Support end-to-end Product Quality Strategy, Life Cycle Management, Growth innovation, Value creation. Other projects include support generation of global and regional consumer and product quality insights through data analytics to help drive innovation and lifecycle management changes.

Support in Due Diligence and Historical Product Assessments for Licensing & Acquisition and Product Licensing Initiatives. Represent Quality on Self-Care Project teams, on need basis. Lead Quality sub-team as required in support of Global projects. Facilitates the regional QRB on behalf of APAC Franchise Quality Lead.
- Support the strategic quality direction as determined by APAC Franchise Quality Lead working closely with the Regional SC Franchise Lead (Self-care), MS&T, R&D and IMO on continuous improvement of commercial products, acquisitions and exit strategies for divestures and NPI; Supports in resolution of quality issues, coordinates the issue response and market actions.
- Participate in product risk assessments, De-risking, providing quality guidance on regulations, classifications, compliance and Q&C strategy to business partners in collaboration with respective Quality pillar leaders including MAKE Quality (IM/EM) and Quality System and Performance Leader.
- Coordinate Quality due diligence activities supporting projects for the AP region.
- Perform investigation related to quality issues working closely with MAKE Q&C, MST, R&D and CQ. Facilitates the regional QRB on behalf of APAC Franchise Quality Lead.
- Recommend Product Quality roadmap for Self Care products - (projects, CIPs, NPI launching, manufacturing network).
- Support product alignment in Q&C in collaboration with other Quality functions for regional/global escalations and field actions.
- Facilitates the regional QRB.
- Support product risk assessments, De-risking, supporting quality guidance on regulations, classifications, Compliance and Q&C strategy to business partners.
- Provide Quality recommendation for siting / sourcing / network decisions.
- Oversight Q&C activities supporting acquisition or divestiture activities.
- Translating business strategy into Quality standards and systems.
- Supporting product alignment in Q&C for products within global Self Care portfolio
- Consulted on regional product change controls, NC, CAPA that would need to be communicated to GFQL for global formulae.
- Support for regional PED & PLI projects - coordinating with R&D Q&C and CQ partners.

**Qualifications**
- Minimum Degree in Pharmacy, Pharmaceutical Sciences or relevant course
- Minimum 10 years of experience in Quality and Compliance function
- Understanding of regional regulatory requirements for Pharmaceuticals as per the franchise needs. An understanding of ICH standards, New Drug Development process, Technical Transfer, and Process Validation is required.
- Experience leading complex projects. Ability to motivate, lead, supervise and partner with people to accomplish project work objectives.
- Technical problem-solving skills.
- Knowledge of statistical tools/methodology, analytical and/or microbiological techniques, and drug processing preferred. Able to collaborate across pillars in Quality to be the representative of Quality to our business partners.

**Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health.**

**Primary Location**
Singapore-Singapore-Singapore
- **Organization**
Johnson & Johnson Pte. Ltd. (8435)
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