Baru Senior Executive Commercial Quality Services, SEA

Date Posted: Posted8 hari yang lalu
Salary:
Johnson & Johnson Family of Companies
Indonesia
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Job Description

The Senior Specialist Commercial Quality Services is responsible for the execution of Quality Management Systems and compliance single point of contact for Commercial Quality related matters to Deliver operations at countries and liaise with multiple organizations to drive timely resolution of quality related issues. This role will also support the execution of Commercial quality related matters to ensure the compliance of the region to global quality standards across the 3 sectors.

The role will continuously improve quality, cost and time factors, consistent with Segment and Deliver business objectives. Identify significant business issues, prioritise for action, and lead improvement opportunities and problem solutions.

Responsible for execution and support of quality assurance programs to ensure effective and consistent processes with established standards by performing the following:

Quality Management System

  • Support Deliver Operations with periodic metrics, dashboard report preparation to identify areas of improvement
  • Coordinate and perform timely reporting on metrics and analysis evaluation in alignment with Deliver Operations and LOC Commercial Quality and administer reporting in Curve/PRISM where applicable.
  • Partner with Deliver Operations and AP shared services on handling of distribution complaints by identifying any GxP related complaints that require follow up with respective Segment complaint handling process.
  • Support implementation of any improvement programs in selected distribution center
  • Support Quality System initiatives to roll out standardized IT systems and develop or build on existing processes across SEA to meet business needs and promote consistency and simplification.
  • Support CQS Manager to ensure compliance to all J&J Quality Policy, Quality policy standards and Technical Standards and regulatory requirements, where applicable, by identifying the gaps and potential risks are mitigated
  • Support CQ teams during regulatory inspections and internal audits as needed.

Quality Projects and Operations

  • Provide quality input to equipment qualification, temperature mapping, logistics-related shipping and distribution change management. Review and approve protocols and reports.
  • Responsible as the Quality designee approval for temperature / humidity mapping, equipment qualification, warehouse change management and logistics change. Support LOC Commercial Quality with investigations related to temperature-controlled in shipping and storage, repack and relabelling, pest control, warehousing infrastructure management. Partner with Deliver Operations to implement business solutions and lead compliance efforts associated with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process.
  • Liase with Temperature COE team to support LOC Commercial Quality and Deliver Operations on Temperature Excursion processes from customer enquiry, temperature controlled / cold chain e.g., vaccine issue management.
  • Deploy and optimise quality systems/processes and ensure alignment with LOC Commercial Quality and provide a measurable impact to quality, cost, and customer value
  • Ensure compliance to current local regulations and assess the impact on changes to quality and distribution practices such as local FDA as well as Department of Health (DoH) standards organisation such as ISO.
  • Execute and maintain quality assurance standards, which adhere to Good Manufacturing Practices including GWP/GDP, Quality System and ISO regulations (if applicable).
  • Proactively identify critical business compliance risk and prioritise appropriate action to lead timely problem solutions.

Compliance

  • Support and lead as needed DC, Distributor and related supplier for local FDA, ISO and JJRC inspections including escalation communication and coordination with local commercial quality organisation as per defined J&J standards.
  • Responsible for timely and accurate metrics reporting in Curve for external inspections.
  • Escalate any critical / significant issues to relevant leadership teams and collaborate with stakeholders to manage the investigation and mitigation actions
  • Support LOC Commercial Quality on JJRC audit and represent DELIVER related supplier management processes
  • Manages and maintains the Commercial Quality Manual for the SEA region

Distributor and Supplier Quality Management

  • Lead qualification for distribution center, distributor plus, logistics and transportation suppliers.
  • Establish/maintain Quality Agreements with DELIVER suppliers (e.g. 3PL’s, distributor & transporter service providers) & DELIVER related suppliers e.g. calibration & maintenance, pest control & cleaning agencies.
  • Influence and enforce the standards and processes stipulated in the Quality Agreement to foster culture of quality throughout the organisation and external partners eg Training Timeliness, CAPA Timeliness etc
  • Conduct or lead 3PL DC, Distributor, and supplier audits of Quality Systems requirements as per SEA supplier audit strategy and procedures.

Qualifications
  • Graduate in Bachelor’s degree in Science or Pharmaceutical Science.
  • Experienced in a quality role. Generally, requires 5 years related experience.
  • Cross-Functional Experience within Q&C.
  • Self-motivated, strong interpersonal skills, good service mind with "can do" attitude.
  • Experience in project management
  • Working knowledge of quality and operations systems and processes.
  • Leadership, collaboration, and interpersonal skills.
  • Communication, presentation, and management skills.
  • Displays initiative and able to independently create and deliver.


Primary Location
Singapore-Singapore-Singapore-
Other Locations
Asia Pacific-Malaysia, Asia Pacific-Vietnam, Asia Pacific-Philippines, Asia Pacific-Indonesia, Asia Pacific-Thailand
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Quality
Requisition ID
2105991031W

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Job Detail

  • Job Id
    6eb1463ff9a355e1
  • Location
    Indonesia
  • Company
    Johnson & Johnson Family of Companies
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

Contact Johnson & Johnson Family of Companies

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