SENIOR MANAGER, CLS QUALITY & COMPLIANCE-4937121210
SENIOR MANAGER, CLS QUALITY & COMPLIANCE
Medical Device & Diagnostics
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.
The Senior Manager (RDC Singapore) CLS Q&C is accountable for the oversight and execution of Quality Management Systems and compliance at Distribution centers in RDC Singapore that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
This role serves a single point of contact to CLS operation lead on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
He/She defines and implements departmental strategies and services as the business expert on quality systems, distribution, and quality management. In collaboration with Enterprise CLS Quality and sectors, develops common distribution standards and Quality Management System and implements accordingly.
The Senior Manager optimizes quality systems and processes and ensures alignment with the worldwide business, the quality vision, and provides a measurable impact to quality, cost, and customer value.
He/She will identify opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. He/She will also identify significant business issues, prioritize for action, and lead improvement opportunities and problem solutions. The Senior Manager will understand current and emerging regulations and the impact to quality and distribution practices.
This individual 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.
This position reports to Senior Director CLS Quality, Asia Pacific.
Distribution and Inventory Management Processes
- Accountable for overseeing the controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation)
- Accountable for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the Distribution Centers.
- Responsible for evaluating the company's quality and distribution process capabilities against company and industry standards and regulatory expectations.
Special Processes (Product Testing, Repack-Relabel)
- Accountable for physical product testing in DC (incoming) (e.g. functional testing, visual inspection & verify.)
- Accountable for physical product testing external (incoming) (e.g. functional testing, visual inspection & verify.)
- Accountable for the QA release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC
- Responsible for defining requirements for repackaging and relabeling operations to be conducted within the Distribution Center and assess repackaging and relabeling requests and partners with business partners to met requirements.
- Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
- Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner
- Accountable for the investigation of temperature control excursions and subsequent remediation activities
Quality Management Systems
- Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
- Responsible for overseeing the controls and quality standards for Quality systems validation, including WMS, Cal/PM, CAPA, NC, IA, Doc mgmt software systems
- Accountable for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, other
- Responsible for management of Management Reviews of the DC
- Accountable for the successful management of all Health Authority inspections (e.g., FDA) as well as other logistics and transportation related inspections (e.g., TSA) conducted
- Responsible for the proactive identification and mitigation of compliance risk at the DCs through QScan, internal audits, and other compliance programs.
- Accountable and responsible for timely and accurate metrics and reports per J&J policies. Reporting responsibilities within North America include (but are not limited to):
- QScan execution
- Metric evaluation and reporting in EDGE
- EDGE entry updates
- Execution of Distribution Center Management Reviews
- Responsible and accountable for the management of facility licenses
- Establish appropriate goals and objectives, and business measurements for department
Distribution Supplier Quality Management
- Accountable for establishing Quality Agreements with distribution, logistics, transportation, and material suppliers
- Accountable for the Qualification of distribution, logistics, transportation, and material suppliers
- Accountable for the Quality management of distribution, logistics, transportation, and material suppliers
Responsible for 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.
Responsible for the overall direction, coordination, structure, and evaluation of staff
Temperature control and cold chain responsibilities for APAC
- Responsible for developing APAC strategy for Temperature control and cold chain in co-ordination with Global Temperature Control Center of Excellence (CoE)
- Accountable for qualifying regional solutions, verifying transportation routes and supporting procurement and supplier management.
- Monitor regional NCR/CAPA and deviations in Temp control and cold chain areas and provide preventive solution working with each sector
- Plays expert role for management of temperature control and monitoring requirements within facility and during transportation.
- Support regional sector QA team for validation of cold chain facilities, and validation of cold chain and controlled ambient pack out & transportation lanes
- Master degree with concentration in Science (Life Sciences, Microbiology, etc) required.
- MBA would be a plus.
- 8-10 years in Pharma or Medical Device industry experience.
- Demonstrated knowledge and experience in quality or operations function.
- Task oriented with proven experience in the delivery high quality work
- Fluency in English language required.
- Strong communication skills
- Strong work ethic, integrity and respect
- Proficiency in Microsoft Office (PowerPoint) another tools required to develop training materials
This role is to be based in Singapore. No relocation support will be provided.
APPLICATION DEADLINE: 24 JANUARY 2013
Primary Location: Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Compliance
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