Associate Commercial Quality Manager

6 days ago


กรงเทพมหานคร, Thailand Johnson & Johnson Full time

**Associate Manager - Thailand Commercial Quality**

This role responsible for End-to-End (E2E) support of Commercial NPD, Promotion, Repack/Relabel, NC/CAPA, Escalation, Change Control, Product Disposition and Process Improvement.

To maintain the consistent E2E approach and retain the domain expertise, this role will also be responsible for MedTech Sector of the following areas:

- Quality System Management (Document Control, NC/CAPA, Change Control, New Procedure Deployment, and Management Review)
- Audit and Inspection Management (Internal and External including HA Inspection)
- SME of NC/ CAPA, document control, purchasing control quality system

CQ lead for quality and regulatory compliance for TH & CLM countries, work with commercial and RA for innovative quality process to support business to achieve the target and long-term plan.

This role also responsible for the execution of Quality Management Systems and compliance at Distribution Center (3PL) and related suppliers for Thailand.

In addition, this person has been assigned as Controlled Substances Responsible Person. This role responsible for the execution of the controlled substances procedures along with local regulations.

Country in Scope: Thailand including Myanmar, Cambodia and Laos

**Key responsibilities**:
1) Manage Q&C system, process in Sale and Marketing Company according to Thai FDA regulatory, J&J policy and requirement, regional procedures and GMP related standards.

2) Managing new product introduction
- Lead overall quality requirements for NPD of Pharm and MedTech.
- Lead to solve quality issue with cross functional team to ensure product launch on time with no significant quality issue.
- Ensure re-dressing and repackaging product meet quality and regulatory compliance.
- Coordinating with Manufacturing site for transportation test and inform inspection results to all related persons.
- Coordinating with Manufacturing company for investigation report of quality issue from imported goods or from transportation test.

3) Managing Repack/Relabel practices including POLO
- Ensure all packaging design, artwork, date format meet all Thai FDA and J&J requirements.
- Ensure quality requirements are communicated to cross functional team.
- Partner with supply chain to ensure repacking and relabeling requirement for FG is done prior distribution.
- Coordinate with LOC and SEA for POLO to meet the POLO requirements.

1) Quality and Compliance
- Ensure the process work compliance to the J&J procedures (SOP and WI)
- Change Control Management: Product information change management e.g., shelf life, artwork, packaging, MFG site change.
- Ensure Quality Agreement is available with Distributor, Distribution Center, Supplier and Manufacturing Site.
- Escalate any quality issue according to procedure.
- Support Quality KPI
- Support audit readiness for LOC and SEA

2) Managing Product at Distributor and Distribution center (Thailand, Cambodia, Myanmar and Laos).
- Partners with the APAC Commercial Quality Excellence team to collaborate and ensure adherence to internal and Health Authority requirements for the identified areas of responsibility and compliance to J&J Quality Policy and Procedures.
- Ensure the quality system requirement is implemented at distributor.
- Manage and control product non‐conformance at distributor and distribution center and coordinate with partner to ensure only good products are released to customer.
- Coordinate with Global and local team to conduct the rework for non‐conformance product and ensure product release process after rework.
- Coordinate with cross functional team and manufacturing site to investigate the quality issue and ensure CAPA is implemented properly.
- Support and lead as needed DC and related supplier for local FDA, ISO and JJRC inspections including escalation communication and coordination with local business quality organization as per defined on J&J standard.
- Respond and support 3PL quality team for general related J&J’s quality issues at 3PL DCs follow the established Quality Agreement.
- Provide quality training and ensure the related functions and partner are understand J&J procedures and requirements.
- Manage the product return process.
- Simplify the processes and practices in the country.

3) Commercial support and Process improvement
- Support commercial to response to customer for the question or information to support product launch or bidding process.
- Others assigned work from supervisors to support the business and help to develop leadership skills.

1) Perform approval as approver and/or QL delegated role in the following systems and relevant procedures.
- TrackWise system: Perform approver role for the Local/LOC impacted change control.
- TruVault: Perform Document Controller and/or Department approval.
- POLO approval.

**Qualifications**:
**Required Qualification and Core Competencies for the role**:
**Education**:

- At least BSc. in Science or Pharmacy or equival



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