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Global Distribution Quality Assurance Leader Job
Date: Jan 16, 2012
Location: Phoenix, AZ, US
Job ID: 101022
Global Distribution Quality Assurance Leader-101022
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 50 years.
The Gore Medical Products Division is seeking a dynamic individual to partner with the Global Logistics Operations Team who are responsible for designing, implementing, and maintaining the warehouse and distribution systems to achieve the business objective of improving efficiencies in the global distribution of finished medical products.
Responsibilities include:
Collaborate with the Global Logistics Team, Business Unit Operations Leadership, Business Unit Quality Leadership and Regulatory Associates to develop a long-term strategy for global warehousing and distribution operations / systems based on business objectives.
Development of the distribution strategy will involve:
* Liaise with regional Associates performing warehouse and distribution operations to identify and understand current processes
* Collaborate on the implementation of the Logistics Operations Master Plan to define the requirements for applicable facility additions and modifications to existing distribution activities based on best practices.
* Develop strategies for Quality System subsystems to support regional warehousing and distribution program operations while maintaining adequate links with the MPD Quality System, including:
* Implement a Quality System subsystem considering regional regulatory, policy, licensing requirements, while maintaining adequate links with the MPD Quality System
* Implement a Quality System subsystem capable of controlling receiving, handling, storage, distribution, regional over-labeling processes, product 'do not distribute' location hold processes, returned product processing, and complaint notifications, regionally.
* Implement use of validated software systems to maintain traceability and global distribution data (ERP, WMS, etc.)
* Collaborate on the identification, evaluation, selection and start-up of third party distribution service providers.
* Develop and implement consistent processes used by distributors, agents, local sales offices, etc. for:
* Limited distribution of clinical trials,
* New country/region set-up for limited distribution
* New Country/region set-up for full distribution
* Existing Country/region on-going distribution
* Control and management of consignment and sales stock inventories.
* Discontinuation of distribution
Monitor, measure, and analyze the processes and document the analyses in quality reports, in order to;
* Determine audit requirements
* Assess risks related to current warehouse and distribution operations, identifying opportunities for improvement and proposing solutions
Support regulatory / compliance inspections or audits conducted by external agencies, as well as internal MPD quality system audits.
Provide strong leadership and mentorship to GORE's Global Warehouse and Distribution Quality Assurance associates.
* Help lead the Warehouse and Distribution Quality Assurance function globally
* Help develop strategic Warehouse and Distribution QA resource plans
* Prioritize Warehouse and Distribution QA activities in alignment with operating unit and Business Unit Leadership priorities
* Develop training modules and communication tools to support the global warehousing and distribution systems.
Qualifications
Required:
* Bachelor's degree in international business, global business management, science or engineering, or
* A two-year degree plus significant medical device industry experience, or
* Significant medical device industry experience working in a Quality Assurance role and heavily involved in the use of quality systems.
Experience:
* At least seven (7) years medical device, pharmaceutical or similarly regulated industry experience in quality assurance.
* Must be able to demonstrate strength and proficiency in the following skill areas:
* US regulations and international standards (e.g., 21 CFR Part 820, ISO 13485:2003, ISO 14971:2009, Canada Medical Devices Regulations, etc.)
* Quality systems development, implementation and maintenance
* Process and software validation concepts
* Vendor and process/systems auditing
* Document control and change management
* Written and oral communication
* Interpersonal relationships
* Ability to coach, teach, and mentor
* Ability to partner broadly
* Ability to work independently as well as be part of a diverse team
* Ability to prioritize and multi-task, setting and meeting aggressive timelines
* Highly motivated with strong interpersonal skills
* Conflict resolution
* Basic computer skills in MS Word, Excel, PowerPoint, Visio, Lotus Notes, etc..
Desirable:
* Multi-lingual
* International business knowledge
* Facility or quality system start-up experience
* Quality support of logistics operations
* Lead auditor certification
* Experience in supporting Global Regulatory inspections/audits (US FDA and/or Notified Body inspections/audits or other similar regulatory body inspections).
EEO/AA Employer (applies to all positions located in the U.S.)
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Job
: Quality
Primary Location
: North America-United States-Arizona-Phoenix
Travel
: Yes, 25% of the time
Shift
: Day (1st shift)
Global Distribution Quality Assurance Leader-101022
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 50 years.
The Gore Medical Products Division is seeking a dynamic individual to partner with the Global Logistics Operations Team who are responsible for designing, implementing, and maintaining the warehouse and distribution systems to achieve the business objective of improving efficiencies in the global distribution of finished medical products.
Responsibilities include:
Collaborate with the Global Logistics Team, Business Unit Operations Leadership, Business Unit Quality Leadership and Regulatory Associates to develop a long-term strategy for global warehousing and distribution operations / systems based on business objectives.
Development of the distribution strategy will involve:
* Liaise with regional Associates performing warehouse and distribution operations to identify and understand current processes
* Collaborate on the implementation of the Logistics Operations Master Plan to define the requirements for applicable facility additions and modifications to existing distribution activities based on best practices.
* Develop strategies for Quality System subsystems to support regional warehousing and distribution program operations while maintaining adequate links with the MPD Quality System, including:
* Implement a Quality System subsystem considering regional regulatory, policy, licensing requirements, while maintaining adequate links with the MPD Quality System
* Implement a Quality System subsystem capable of controlling receiving, handling, storage, distribution, regional over-labeling processes, product 'do not distribute' location hold processes, returned product processing, and complaint notifications, regionally.
* Implement use of validated software systems to maintain traceability and global distribution data (ERP, WMS, etc.)
* Collaborate on the identification, evaluation, selection and start-up of third party distribution service providers.
* Develop and implement consistent processes used by distributors, agents, local sales offices, etc. for:
* Limited distribution of clinical trials,
* New country/region set-up for limited distribution
* New Country/region set-up for full distribution
* Existing Country/region on-going distribution
* Control and management of consignment and sales stock inventories.
* Discontinuation of distribution
Monitor, measure, and analyze the processes and document the analyses in quality reports, in order to;
* Determine audit requirements
* Assess risks related to current warehouse and distribution operations, identifying opportunities for improvement and proposing solutions
Support regulatory / compliance inspections or audits conducted by external agencies, as well as internal MPD quality system audits.
Provide strong leadership and mentorship to GORE's Global Warehouse and Distribution Quality Assurance associates.
* Help lead the Warehouse and Distribution Quality Assurance function globally
* Help develop strategic Warehouse and Distribution QA resource plans
* Prioritize Warehouse and Distribution QA activities in alignment with operating unit and Business Unit Leadership priorities
* Develop training modules and communication tools to support the global warehousing and distribution systems.
Qualifications
Required:
* Bachelor's degree in international business, global business management, science or engineering, or
* A two-year degree plus significant medical device industry experience, or
* Significant medical device industry experience working in a Quality Assurance role and heavily involved in the use of quality systems.
Experience:
* At least seven (7) years medical device, pharmaceutical or similarly regulated industry experience in quality assurance.
* Must be able to demonstrate strength and proficiency in the following skill areas:
* US regulations and international standards (e.g., 21 CFR Part 820, ISO 13485:2003, ISO 14971:2009, Canada Medical Devices Regulations, etc.)
* Quality systems development, implementation and maintenance
* Process and software validation concepts
* Vendor and process/systems auditing
* Document control and change management
* Written and oral communication
* Interpersonal relationships
* Ability to coach, teach, and mentor
* Ability to partner broadly
* Ability to work independently as well as be part of a diverse team
* Ability to prioritize and multi-task, setting and meeting aggressive timelines
* Highly motivated with strong interpersonal skills
* Conflict resolution
* Basic computer skills in MS Word, Excel, PowerPoint, Visio, Lotus Notes, etc..
Desirable:
* Multi-lingual
* International business knowledge
* Facility or quality system start-up experience
* Quality support of logistics operations
* Lead auditor certification
* Experience in supporting Global Regulatory inspections/audits (US FDA and/or Notified Body inspections/audits or other similar regulatory body inspections).
EEO/AA Employer (applies to all positions located in the U.S.)
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Job
: Quality
Primary Location
: North America-United States-Arizona-Phoenix
Travel
: Yes, 25% of the time
Shift
: Day (1st shift)
Nearest Major Market: Phoenix
Job Segments: Administrative, Business Manager, Change Management, Compliance, Distribution, Document Control, Engineer, Engineering, ERP, Facilities, Healthcare, Law, Legal, Management, Manufacturing, Medical Device, Operations, Pharmaceutical, Pharmaceutical Sales, QA, Quality, Quality Assurance, Sales, Science, Technology, Warehouse