Sr. QA Associate, Transportation & Temperature Control Q&C-00000EDE
Description
Within Johnson & Johnson Consumer Europe, the ELC (European Logistics Center) is responsible for effectively supplying Marketing and Sales affiliates throughout Europe, Middle East and Africa. This involves responsibilities such as managing commissionaire and toll manufacturing agreements in the region as well as channeling demand and intercompany transactions via the ELC operating systems. We are looking for a
Sr. QA Associate, Transportation & Temperature Control Q&C
Role Overview
The Senior QA Associate Transport & Temperature Control Quality & Compliance, Customer & Logistic Services / Market Quality & Compliance (CLS Q&C) EMEA report solid line to the Senior Manager EMEA Transport & Temperature Control CLS / Market Quality & Compliance.
The position is accountable for the oversight and execution of Quality Management Systems and Compliance within EMEA of the Transport & Temperature Control activities (primary shipment and secondary shipment) related to Medicinal Products, Medical Devices, Cosmetics and commodities shipments.
The position serves as a single point of contact to the CLS operational leads for Transportation & Temperature Control Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues (e.g. NC/CAPA, Customer Complaints).
The position 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. The position identifies opportunities to continuously improve quality, cost and time factors, consistent with objectives. Identifies significant business issues, prioritize for action, and support improvement opportunities and problem solutions. The position understands current and emerging regulations and the impact to quality and distribution practices.
The position 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.
Major Responsibilities
Transportation and Temperature Control Management Processes
Temperature Control & Monitoring
Quality Management Systems
Compliance
Carriers / Control towers Quality Management
Experience and key competencies
This role requires a diverse business background, preferably with direct experience in pharmaceutical or medical devices sector, with specific quality, regulatory and regulatory compliance competencies in the areas of: customer service, Distribution Centers or transportation. A minimum of 5 years of experience in positions of increasing responsibility, with broadly based quality management experience. Experience with the global demands of the role specifically: healthcare regulatory requirements.
Proven success in:
• Pharmaceutical DC or Transport Q&C management.
• Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority.
• Compliance experience, QMS experience.
• Change management and project management experience.
• Strong presentation skills.
• Issue remediation experience.
• Collaborative approach.
• Managing complexity.
• Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
• Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
Qualifications
Personal Attributes
• Organized, and able to lead people within a complex social, cultural and political environment.
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• "hands-on" operational orientation.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict.
• Ability to fit in well culturally in a complex organization.
• Fluent in English, and at least one additional language spoken in Europe.
Education
Required: Undergraduate degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent of 10 years relevant industry experience if no degree.
Location
Location is Zug with requirement of 25% travel within Europe.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Travel:Yes, 25 % of the Time
Job Function: Quality (Generalist)
Description
Within Johnson & Johnson Consumer Europe, the ELC (European Logistics Center) is responsible for effectively supplying Marketing and Sales affiliates throughout Europe, Middle East and Africa. This involves responsibilities such as managing commissionaire and toll manufacturing agreements in the region as well as channeling demand and intercompany transactions via the ELC operating systems. We are looking for a
Sr. QA Associate, Transportation & Temperature Control Q&C
Role Overview
The Senior QA Associate Transport & Temperature Control Quality & Compliance, Customer & Logistic Services / Market Quality & Compliance (CLS Q&C) EMEA report solid line to the Senior Manager EMEA Transport & Temperature Control CLS / Market Quality & Compliance.
The position is accountable for the oversight and execution of Quality Management Systems and Compliance within EMEA of the Transport & Temperature Control activities (primary shipment and secondary shipment) related to Medicinal Products, Medical Devices, Cosmetics and commodities shipments.
The position serves as a single point of contact to the CLS operational leads for Transportation & Temperature Control Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues (e.g. NC/CAPA, Customer Complaints).
The position 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. The position identifies opportunities to continuously improve quality, cost and time factors, consistent with objectives. Identifies significant business issues, prioritize for action, and support improvement opportunities and problem solutions. The position understands current and emerging regulations and the impact to quality and distribution practices.
The position 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.
Major Responsibilities
Transportation and Temperature Control Management Processes
Temperature Control & Monitoring
Quality Management Systems
Compliance
Carriers / Control towers Quality Management
Experience and key competencies
This role requires a diverse business background, preferably with direct experience in pharmaceutical or medical devices sector, with specific quality, regulatory and regulatory compliance competencies in the areas of: customer service, Distribution Centers or transportation. A minimum of 5 years of experience in positions of increasing responsibility, with broadly based quality management experience. Experience with the global demands of the role specifically: healthcare regulatory requirements.
Proven success in:
• Pharmaceutical DC or Transport Q&C management.
• Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority.
• Compliance experience, QMS experience.
• Change management and project management experience.
• Strong presentation skills.
• Issue remediation experience.
• Collaborative approach.
• Managing complexity.
• Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
• Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
Qualifications
Personal Attributes
• Organized, and able to lead people within a complex social, cultural and political environment.
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• "hands-on" operational orientation.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict.
• Ability to fit in well culturally in a complex organization.
• Fluent in English, and at least one additional language spoken in Europe.
Education
Required: Undergraduate degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent of 10 years relevant industry experience if no degree.
Location
Location is Zug with requirement of 25% travel within Europe.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Travel:Yes, 25 % of the Time
Job Function: Quality (Generalist)