Director of Data Integrity
hace 2 meses
We are looking for a Director of Data Integrity to join our client in Guadalajara, Mexico. Our client has over 75 years of experience and is a commercial organization focused on the development, manufacturing and sterilization of complex medical device and pharmaceutical products.
**Responsibilities**
- Define and implement a data integrity governance program and provide strategic leadership for the establishment of a robust data integrity program based on risk analysis. In addition to identifying opportunities and implementing medium to long term strategies to mitigate data integrity risks based on trends and new developments in the data integrity industry.
- Lead the escalation of all data integrity related issues to site management levels as needed.
- Provide oversight for the governance, management and coordination of activities related to the Data Integrity Program, which includes, but is not limited to, leading, developing and maintaining data integrity compliance activities throughout the product lifecycle in alignment with regulations and GMP guidelines. Drive continuous / sustainable improvement in data integrity risk detection and mitigation through self-inspection program, continuous improvement program, Gemba walks, etc.
- Identify training needs, design, develop and deliver data integrity training on a regular frequency.
- Ensure compliance with all regulatory requirements related to data integrity, company policies and procedures, including security rules and regulations. Identify high-risk processes and data systems (through risk assessment, gap analysis, data mapping, etc.) and implement mitigation actions.
- Interact directly with FDA, other regulatory agencies and auditors on all issues related to data integrity. This includes supporting preparation for customer inspections, health authorities and/or responding to observations during audits.
**Qualifications and Experience**
- Bachelor’s Degree plus a 10 years experience in the pharmaceutical/biopharmaceutical industry supporting manufacturing and quality operations.
- Experience and in-depth knowledge of GxP computerized systems validation and 21 CFR Part 11, GAMP 5 and CSV requirements (including cloud systems, agile software development validation), methods validation and IT infrastructure qualification. Experience in US FDA, UK MHRA, PIC/s, EU, TGA, etc. data integrity guidelines.
- Experience in FDA regulated environment - US 21 CFR Part 210 & 211 Current Good Manufacturing Practice. Experience in dealing directly with FDA.
- Cross-functional experience in the pharmaceutical industry regulated by GxPs (i.e. manufacturing, engineering, quality assurance, quality control, etc.).
- Direct experience related to data integrity in the pharmaceutical/biopharmaceutical industry. Strong experience in data integrity program support, risk analysis, project and budget management.
- In-depth knowledge of data integrity requirements US FDA, UK MHRA, PIC/s, EU, TGA, etc.
- In-depth knowledge in validation of computerized GxP systems.
- In-depth knowledge in the requirements of 21 CFR Part 11, GAMP 5 and data integrity guidelines of USFDA, UK MHRA, PIC/s, EU, TGA, etc.
- Expert level knowledge and understanding of cGMP.
- Pharmatech Associates, Inc. provides _**_equal employment opportunity_**_ to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law._
Tenemos otros empleos actuales relacionados con este campo que puede encontrar a continuación
-
Director Of Operations
hace 1 mes
guadalajara, México Foxconn Corporation A tiempo completoDirector Of Operations Flextronics11.05.2024Director Of Operations Jalisco, Jalisco Jalisco Flextronics 11.05.2024 Director Of Operations Flex Ayer Director Of Operations Jalisco, Jalisco Jalisco Flex Ayer Director Of Operations Ayer Director Of Operations Jalisco, Jalisco Jalisco Foxconn Corporation Ayer Dire... Leer más...Director Of Operations...
-
Director Of Operations
hace 2 días
Guadalajara, Jalisco, México Flextronics A tiempo completoDirector Of Operations Flex Ayer Director Of Operations Jalisco, Jalisco Jalisco Flex Ayer Director Of Operations Ayer Director Of Operations Jalisco, Jalisco Jalisco Foxconn Corporation Ayer Director of Operations Flex Director of Operations 44009 Guadalajara, Jalisco Flex 0... Leer más... Director Of Operations Jalisco, Jalisco Jalisco Foxconn...
-
Director Of Operations
hace 1 mes
guadalajara, México Flextronics A tiempo completoDirector Of Operations FlexAyerDirector Of Operations Jalisco, Jalisco Jalisco Flex Ayer Director Of Operations Ayer Director Of Operations Jalisco, Jalisco Jalisco Foxconn Corporation Ayer Director of Operations Flex 01.05.2024 Director of Operations 44009 Guadalajara, Jalisco Flex 0... Leer más...Director Of Operations Jalisco, Jalisco...
-
Director Of Operations
hace 2 semanas
guadalajara, México Flextronics A tiempo completoDirector Of Operations FlexAyerDirector Of Operations Jalisco, Jalisco Jalisco Flex Ayer Director Of Operations Ayer Director Of Operations Jalisco, Jalisco Jalisco Foxconn Corporation Ayer Director of Operations Flex 01.05.2024 Director of Operations 44009 Guadalajara, Jalisco Flex 0... Leer más...Director Of Operations Jalisco, Jalisco...
-
Director Of Operations
hace 3 días
Guadalajara, Jalisco, México Flextronics A tiempo completoDirector Of OperationsFlexAyerDirector Of OperationsJalisco, Jalisco JaliscoFlexAyerDirector Of Operations Ayer Director Of Operations Jalisco, Jalisco Jalisco Foxconn Corporation Ayer Director of Operations Flex Director of Operations 44009 Guadalajara, Jalisco Flex 0...Leer más...Director Of OperationsJalisco, Jalisco JaliscoFoxconn Corporation Director...
-
Head of Data
hace 2 meses
Guadalajara, México Improvado A tiempo completoImprovado is revolutionizing the way RevOps in large enterprises access and use data. Headquartered in San Francisco, with teams across 25 countries, we are united by our passion for transforming marketing technology. Our cutting-edge, no-code revenue data platform simplifies marketing reporting, enables informed budget decisions, and increases the ROI of...
-
Head of Data
hace 2 días
Guadalajara, México Improvado A tiempo completoImprovado is revolutionizing the way RevOps in large enterprises access and use data. Headquartered in San Francisco, with teams across 25 countries, we are united by our passion for transforming marketing technology. Our cutting-edge, no-code revenue data platform simplifies marketing reporting, enables informed budget decisions, and increases the ROI of...
-
Data Integrity Analyst
hace 3 días
Guadalajara, Jalisco, México Geodis A tiempo completoGeneral information:Legal entity :GEODIS is a leading global logistics provider acknowledged for its expertise across all aspects of the supply chain.As a growth partner to its clients, GEODIS specializes in five lines of business: Supply Chain Optimization, Global Freight Forwarding, Global Contract Logistics, Distribution & Express, and European Road...
-
Director Of Operations
hace 3 días
Guadalajara, Jalisco, México Foxconn Corporation A tiempo completoDirector of Operations Director of Operations 44009 Guadalajara, Jalisco Jalisco ???????????? Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New product launch, order managemen.. Leer más... Director Of Operations Jalisco, Jalisco Jalisco...
-
Director Of Operations
hace 3 semanas
guadalajara, México Foxconn Corporation A tiempo completoDirector of Operations 20.05.2024Director of Operations 44009 Guadalajara, Jalisco Jalisco 鴻海精密工業股份有限公司 20.05.2024 Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer’s requirements: New product launch, order managemen... Leer...
-
Director Of Operations
hace 3 días
Guadalajara, Jalisco, México Foxconn Corporation A tiempo completoDirector of Operations Director of Operations44009 Guadalajara, Jalisco JaliscoJob Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New product launch, order managemen...Leer más...Director Of OperationsJalisco, Jalisco JaliscoFlextronics Director Of...
-
Director Of Operations
hace 1 semana
guadalajara, México Foxconn Corporation A tiempo completoCancelInicio Trabajos para Director Of Operations en Guadal...>74Director of Operations HoyDirector of Operations 44009 Guadalajara, Jalisco 鴻海精密工業股份有限公司 Hoy Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer’s requirements: New...
-
Director Of Operations
hace 3 semanas
guadalajara, México Flex A tiempo completoCancelInicio Trabajos para Director Of Operations en Guadal...>74Director of Operations 20.05.2024Director of Operations 44009 Guadalajara, Jalisco 鴻海精密工業股份有限公司 20.05.2024 Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer’s...
-
Director Of Operations
hace 2 semanas
guadalajara, México Flex A tiempo completoCancelInicio Trabajos para Director Of Operations en Guadal...>74Director of Operations 20.05.2024Director of Operations 44009 Guadalajara, Jalisco 鴻海精密工業股份有限公司 20.05.2024 Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer’s...
-
Director Of Operations
hace 2 días
Guadalajara, Jalisco, México Foxconn Corporation A tiempo completoCancel Inicio Trabajos para Director Of Operations en Guadal... > 74 Director of Operations Hoy Director of Operations 44009 Guadalajara, Jalisco 鴻海精密工業股份有限公司 Hoy Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New...
-
Director Of Operations
hace 2 días
Guadalajara, Jalisco, México Foxconn Corporation A tiempo completoCancelInicioTrabajos para Director Of Operations en Guadal...>74Director of OperationsHoyDirector of Operations44009 Guadalajara, JaliscoHoyJob Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New product launch, order managemen...Director of...
-
Director Of Operations
hace 2 días
Guadalajara, Jalisco, México Flex A tiempo completoCancel Inicio Trabajos para Director Of Operations en Guadal... > 74 Director of Operations Director of Operations 44009 Guadalajara, Jalisco 鴻海精密工業股份有限公司 Job Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New product...
-
Director Of Operations
hace 3 días
Guadalajara, Jalisco, México Flex A tiempo completoCancelInicioTrabajos para Director Of Operations en Guadal...>74Director of Operations Director of Operations44009 Guadalajara, JaliscoJob Description: This position is responsible for leading BU Cell Manager, Production Manager, and New Product Manager (NPI) to satisfy customer's requirements: New product launch, order managemen...Leer más...Director of...
-
Signal Integrity Engineer
hace 3 días
Guadalajara, México INTEL A tiempo completoDelivers signal integrity solutions for large, complex, high-speed platforms, boards, and packages. - Develops a viable space for all interconnects, including 2D and 3D model extracts of electrical structures for the entire die to die interconnect. - Defines signal integrity rules, reviews implementation, documents characterization, and measurement reports,...
-
Signal Integrity Engineer
hace 2 días
Guadalajara, México INTEL A tiempo completoDelivers signal integrity solutions for large, complex highspeed platforms, boards, and packages. - Develops a viable space for all interconnects including 2D and 3D models extracts of electrical structures for the entire die-to-die interconnect. - Defines signal integrity rules, reviews implementation, documents characterization and measurement reports, and...
