Quality Manager-00000ISS
Description
Quality Manager LA North – Requisition Number 00000ISS
“Johnson & Johnson companies are equal opportunity employers”
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Description
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time. Our people, across many different companies, are united in their passionate pursuit of science for the benefit of patients. With employees in over 50 countries, we share the commitment of our corporate parents to bring innovative ideas, products and services to patients throughout the world.
Searching the best talent for: Quality Manager LA North
Band: 30
Position general description
To be the LOC/Cluster lead for the implementation of a Quality Management System (QMS) for all Good Practices (GxP) related activities (pre- and post-marketing) and to ensure, in collaboration with the various LOC/Cluster Good Practices Quality & Compliance leads (e.g. Quality Executives (GMP/GDP), Local Safety Officers, Regulatory, Clinical, etc.), that the implementation meets the requirements of J&J Quality Policy POL-001, applicable regulations and voluntary standards. Note that the Quality Manager may also be one of the specific Good Practices Quality and Control leads.
Main responsibilities
To lead and co-ordinate the LOC/Cluster (GxP) Quality & Compliance leads (the respective GxP Quality & Compliance Council, or Leadership Team) in the development and deployment of a QMS that is applicable to the activities of the local operating companies by:
Establishing and maintaining the local QMS.
Assessing and making recommendations regarding resource and infrastructure required to deploy and maintain the local QMS.
Ensuring that all local processes are compliant and consistent with applicable J&J policies, global and sector standards and global and regional processes (as applicable).
Support the GxP functions to meet their quality and compliance objectives aligned with the on-going conduct of business (e.g. inspection support/guidance)
Ensure the LOC / Cluster is properly represented on any global / regional quality projects and meetings driven by the senior regional Market Quality head.
To share experiences and best practices
To provide feedback on this to the LOC/Cluster GxP Quality & Compliance Council/LT.
Note: the LOC Quality Head may not be the expert in all GxP areas, but can provide a supporting role to the relevant functional area owners via the QMS.
Specific areas of oversight
· Documentation - that GxP process documents are prepared, reviewed, approved, implemented, updated and retained, including archived/deleted, appropriately.
· Training – required training is provided and managed appropriately for all GxP functions.
· Control of Change - appropriate processes and systems are in place across the LOC / Cluster for the management of change with potential impact on quality and compliance.
· Escalation - issues regarding product quality, safety or compliance are escalated per STA-00002.
· Continuous Improvement - a programme of continuous improvement across the GxP areas to ensure product of high quality and compliance.
· Auditing (Internal/Global/External) – appropriate processes and systems in place to effectively manage (before, during, and follow up) GxP audits of LOC/Cluster facilities and any LOC managed contract GxP operations.
· Regulatory Environment – monitoring local GxP/Regulatory requirements in collaboration with other GxP Q&C leads, Regulatory Managers, HCC Officer and local Safety Officer.
· Management Reviews
· Co-ordinate the reviews according to Global SOPs
· Report to the Management Board of the LOC / Cluster for the performance of the QMS by:
· Identifying, coordinating and presenting appropriate metrics, including progress against deliverables, and need for improvement at LOC/Cluster level.
· Ensure escalation of problems with respect to alignment of processes, and potential product quality, safety and/or compliance risks with regard to meeting customer needs and regulatory/legal requirements.
Calificaciones
A background of working in pharmaceutical/biotechnology industries with a substantial experience over 4 years of either Quality Assurance or Process methodologies.
Experience in Quality and Project Management
English 80 - 100% is required
Continuous development into current GxP regulations, guidelines and industry quality standards.
Relevant university degree in Chemichal Pharmaciest.
Influence, leadership and ability to effectively operate at executive / board level, including assertiveness in conflict/challenging situations.
Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker.
Global Leadership Profile Competencies
- Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
- Big Picture Orientation with Attention to Detail ~ able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed
- Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
- Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed
- Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
Relocation and other work permissions
The Company will be/won’t be responsable for posible relocation or permanent expenses, or work permits for this position.
Submit your resume by:
Diciembre 7
Primary Location
Bogota
Organization
J&J MD&D
Ubicación principal: America Latina-Colombia-Distrito Capital de Bogotá-Bogotá
Organización: Janssen Cilag S.A. (7060)
Área: Quality (Eng)
Description
Quality Manager LA North – Requisition Number 00000ISS
“Johnson & Johnson companies are equal opportunity employers”
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Description
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time. Our people, across many different companies, are united in their passionate pursuit of science for the benefit of patients. With employees in over 50 countries, we share the commitment of our corporate parents to bring innovative ideas, products and services to patients throughout the world.
Searching the best talent for: Quality Manager LA North
Band: 30
Position general description
To be the LOC/Cluster lead for the implementation of a Quality Management System (QMS) for all Good Practices (GxP) related activities (pre- and post-marketing) and to ensure, in collaboration with the various LOC/Cluster Good Practices Quality & Compliance leads (e.g. Quality Executives (GMP/GDP), Local Safety Officers, Regulatory, Clinical, etc.), that the implementation meets the requirements of J&J Quality Policy POL-001, applicable regulations and voluntary standards. Note that the Quality Manager may also be one of the specific Good Practices Quality and Control leads.
Main responsibilities
To lead and co-ordinate the LOC/Cluster (GxP) Quality & Compliance leads (the respective GxP Quality & Compliance Council, or Leadership Team) in the development and deployment of a QMS that is applicable to the activities of the local operating companies by:
Establishing and maintaining the local QMS.
Assessing and making recommendations regarding resource and infrastructure required to deploy and maintain the local QMS.
Ensuring that all local processes are compliant and consistent with applicable J&J policies, global and sector standards and global and regional processes (as applicable).
Support the GxP functions to meet their quality and compliance objectives aligned with the on-going conduct of business (e.g. inspection support/guidance)
Ensure the LOC / Cluster is properly represented on any global / regional quality projects and meetings driven by the senior regional Market Quality head.
To share experiences and best practices
To provide feedback on this to the LOC/Cluster GxP Quality & Compliance Council/LT.
Note: the LOC Quality Head may not be the expert in all GxP areas, but can provide a supporting role to the relevant functional area owners via the QMS.
Specific areas of oversight
· Documentation - that GxP process documents are prepared, reviewed, approved, implemented, updated and retained, including archived/deleted, appropriately.
· Training – required training is provided and managed appropriately for all GxP functions.
· Control of Change - appropriate processes and systems are in place across the LOC / Cluster for the management of change with potential impact on quality and compliance.
· Escalation - issues regarding product quality, safety or compliance are escalated per STA-00002.
· Continuous Improvement - a programme of continuous improvement across the GxP areas to ensure product of high quality and compliance.
· Auditing (Internal/Global/External) – appropriate processes and systems in place to effectively manage (before, during, and follow up) GxP audits of LOC/Cluster facilities and any LOC managed contract GxP operations.
· Regulatory Environment – monitoring local GxP/Regulatory requirements in collaboration with other GxP Q&C leads, Regulatory Managers, HCC Officer and local Safety Officer.
· Management Reviews
· Co-ordinate the reviews according to Global SOPs
· Report to the Management Board of the LOC / Cluster for the performance of the QMS by:
· Identifying, coordinating and presenting appropriate metrics, including progress against deliverables, and need for improvement at LOC/Cluster level.
· Ensure escalation of problems with respect to alignment of processes, and potential product quality, safety and/or compliance risks with regard to meeting customer needs and regulatory/legal requirements.
Calificaciones
A background of working in pharmaceutical/biotechnology industries with a substantial experience over 4 years of either Quality Assurance or Process methodologies.
Experience in Quality and Project Management
English 80 - 100% is required
Continuous development into current GxP regulations, guidelines and industry quality standards.
Relevant university degree in Chemichal Pharmaciest.
Influence, leadership and ability to effectively operate at executive / board level, including assertiveness in conflict/challenging situations.
Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker.
Global Leadership Profile Competencies
- Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
- Big Picture Orientation with Attention to Detail ~ able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed
- Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
- Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed
- Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
Relocation and other work permissions
The Company will be/won’t be responsable for posible relocation or permanent expenses, or work permits for this position.
Submit your resume by:
Diciembre 7
Primary Location
Bogota
Organization
J&J MD&D
Ubicación principal: America Latina-Colombia-Distrito Capital de Bogotá-Bogotá
Organización: Janssen Cilag S.A. (7060)
Área: Quality (Eng)
