HireDiversity

Singapore, SG

ASSISTANT MANAGER, CLS QUALITY & COMPLIANCE-5852121220

Description

ASSISTANT MANAGER

Region Distribution Center (RDC)

Enterprise CLS & Market Quality

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Description

The Assistant Manager RDC is responsible for the oversight and execution of Quality Management Systems and compliance at RDC Singapore

The Assistant Manager RDC serves a single point of contact on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

This individual identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions.

This role plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

RESPONSIBILITIES

Distribution and Inventory Management Processes

- Responsible for Quality in product receiving process (incl. receiving inspection) within the DC
- Responsible for disposition of damaged packages (incoming) according to predefined agreements with Source co., Franchise, or Marketing Co.
- Monitoring of product destruction process
- Oversight of Quarantine/hold/stop-ship/recall processes within the DC
- Oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors
- Inventory Quality management, including lot reconciliation within the DC
- Ensuring that Clinical Materials are distributed according to agreed upon requirements with Clinical organization
- Quality management of patient samples and non-J&J product maintained within the DC
- Ensuring returned product is dispositioned according to predefined agreements with Source co., Franchise, or Marketing Co.; responsible for resolving discrepancies in a timely fashion with appropriate partner

Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)

- Physical product testing in DC (incoming) (e.g. functional testing, visual inspection & verif.)
- Physical product testing external (incoming) (e.g. functional testing, visual inspection & verif.)
- Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
- QA release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC
- Validation of cold chain facilities
- Validation of cold chain and controlled ambient packout & transportation lanes
- Validation of cold chain and controlled ambient packout & transportation lanes changes
- Quality management of cold chain packout process
- Monitoring of ambient environment (temperature and humidity as required)
- Management and oversight of temperature control shipments (outgoing)
- Identification and communication of temperature control excursions occurring within the DC to appropriate partner
- Investigation of temperature control excursions and subsequent remediation activities

Quality Management Systems

- Validation of Warehouse Management Systems
- Management of CAPA process and systems
- Records and document management
- Validation, implementation, and changes of Cal/PM, CAPA, NC, IA, Doc mgmt software systems oversight
- Control of current work instructions in the DC
- Responsible for change control
- Training management, including operator certification
- Monitoring of calibration and preventive maintenance systems
- Capture and processing of complaints reported to DC (Product and Service related complaints)
- Management of service related complaints incl. track and trend
- Internal Quality agreements between CLS and LOC / Franchise
- Internal Quality agreements between CLS Quality and site operations Quality

Compliance

- Conducting internal Quality audits of DCs (schedule, plan, conduct, follow up)
- Conducting audits of transportation suppliers and 3PLs associated with the DC
- Management of DC facility licenses
- Management of all Health Authority inspections (e.g. FDA) as well as other logistics and transportation related inspections (e.g., TSA) conducted at all of the DC
- Execution of DC QSCAN risk evaluation

Distribution Supplier Quality Management

- Establishing Quality Agreements with distribution, logistics, transportation, and material suppliers
- Qualification of distribution, logistics, transportation, and material suppliers
- Quality management of distribution, logistics, transportation, and material suppliers

Management

- Carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems.

Site Specific Responsibilities

- Day to day activities of base business.

Qualifications


REQUIRED

- Degree in a Science (chemistry/physics/biotechnology/microbiology)
- MBA preferred
- At least 5-6 years corporate working experience in the pharmaceutical or medical device industry
- Excellent interpersonal & communication skills
- Strong project management skills
- Experience in driving process excellence
- Demonstrate strong planning, organizational and decision making skills
- Good team-player with strong interdependent collaboration partnership
- Results oriented with high sense of urgency
- High integrity, ethical & professional

LOCATION

This position will be based in Singapore. No relocation provided.

APPLICATION DEADLINE: 24 JANUARY 2013

Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Quality (Generalist)