2 Messages
Digest #3294
Messages
Wed Sep 3, 2014 8:14 am (PDT) . Posted by:
"john sampson" jcsspike
John,
This one is located in the Somerville, NJ area
$145k-$155k, + 20%+ options
Associate Director, Quality Assurance - GCP
Job Description
SUMMARY:
Support and foster QA ICH/FDA GCP, Clinical, Medical and Regulatory Compliance. Responsible for quality and regulatory compliance of GCP and assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.
RESPONSIBILITIES:
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice.
- Responsible for quality assurance program in supporting GCP activities; this includes overseeing and assisting with training and auditing programs, development and review of SOPs, as well as conducting vendor and site audits.
- Establish and maintain a risk-based and scientific-based quality system to support Good Clinical Practice.
- Approximately 30% Domestic and International travel (Canada)
- Utilizes a quality system approach to ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
- Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, or customers, to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources.
- Act as company's representative during regulatory agencies and vendor audits.
- Contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
- Partner with colleagues in Clinical, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role, and instill a Quality Improvement approach in all activities.
- Audit and prepare audit reports on the facilities of vendors, Investigator Sites and outside contract organizations.
Qualifications
- Minimum BS degree in Chemistry, Life Science or related discipline and a minimum of ten (10) years QA experience in regulated industry such as pharmaceutical, biologics or device; an advanced degree and a minimum seven (7) years of equivalent experience preferred.
- Full understanding of ICH/FDA GCP guidelines, with a working knowledge of cGMP and GLP is essential.
- Understand device regulations, development processes and FDA inspection procedures is also required.
- Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines.
- Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
- Experience with effectively managing FDA inspections, working with regulators and customer audits.
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
- Ability to conduct internal audits.
- Ability to conduct external audits on CROs - including supporting laboratories, monitoring organizations, writing audit reports, and writing and reviewing CAPAs.
- Broad knowledge of risk based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Excellent written skills, presentation skills and attention to detail.
- Demonstrated ability to work independently and manage variable workloads.
Ray Lancaster
908-526-5440908-526-5440
RFL@Lancasterinc.net
www.LancasterAssociates.net
This one is located in the Somerville, NJ area
$145k-$155k, + 20%+ options
Associate Director, Quality Assurance - GCP
Job Description
SUMMARY:
Support and foster QA ICH/FDA GCP, Clinical, Medical and Regulatory Compliance. Responsible for quality and regulatory compliance of GCP and assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.
RESPONSIBILITIES:
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice.
- Responsible for quality assurance program in supporting GCP activities; this includes overseeing and assisting with training and auditing programs, development and review of SOPs, as well as conducting vendor and site audits.
- Establish and maintain a risk-based and scientific-based quality system to support Good Clinical Practice.
- Approximately 30% Domestic and International travel (Canada)
- Utilizes a quality system approach to ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
- Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, or customers, to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources.
- Act as company's representative during regulatory agencies and vendor audits.
- Contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
- Partner with colleagues in Clinical, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role, and instill a Quality Improvement approach in all activities.
- Audit and prepare audit reports on the facilities of vendors, Investigator Sites and outside contract organizations.
Qualifications
- Minimum BS degree in Chemistry, Life Science or related discipline and a minimum of ten (10) years QA experience in regulated industry such as pharmaceutical, biologics or device; an advanced degree and a minimum seven (7) years of equivalent experience preferred.
- Full understanding of ICH/FDA GCP guidelines, with a working knowledge of cGMP and GLP is essential.
- Understand device regulations, development processes and FDA inspection procedures is also required.
- Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines.
- Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
- Experience with effectively managing FDA inspections, working with regulators and customer audits.
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
- Ability to conduct internal audits.
- Ability to conduct external audits on CROs - including supporting laboratories, monitoring organizations, writing audit reports, and writing and reviewing CAPAs.
- Broad knowledge of risk based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Excellent written skills, presentation skills and attention to detail.
- Demonstrated ability to work independently and manage variable workloads.
Ray Lancaster
908-526-5440908-526-5440
RFL@Lancasterinc.net
www.LancasterAssoci
Wed Sep 3, 2014 8:19 am (PDT) . Posted by:
"john sampson" jcsspike
This one is located in the Parsippany, NJ area
must have Studio and technical integration experience
$120k+15%+options
Business Systems Analyst III (Workday)
Oversees cross-functional teams tasked with solving business issues which require a technical solution providing subject matter expertise with regards to system functionality and capabilities for stakeholders.
·Participates in strategic meetings to review, evaluate, and/or propose new business opportunities through the implementation/enhancement of technical solutions, which are intended to improve customer relationships, operating efficiencies, and/or add business benefits.
·Identifies detailed requirements from business users through interviews, documentation, and facilitated working sessions for approved projects and enhancements.
·Partners with stakeholders and business representatives to identify necessary department resources to meet defined objectives.
·Leads team in analyzing information and prioritizing requirements to gain an understanding of the business needs in order to provide recommendations for solutions. Evaluates relative feedback and ROI to effectively align projects.
·Manages work plans, timelines, and budgets. Assesses project impacts through consultation with the business, management, regulatory, IT, quality assurance, validation, and training teams.
·Creates comprehensive business process models and maps based on requirements, capturing pertinent process step details in design documents so that opportunities for process improvements, benchmarks, key performance indicators, current metrics, and target objectives can be recognized establishing benefits realization objectives.
·Structures and develops test plans (e.g. test objectives, test cases, test data and test scripts) for executing unit, integration, system and/or acceptance testing in order to ensure the solution meets the business requirements.
·Manages acceptance testing with the business users performing system configuration and integration testing including the functionality, performance, and fit-for-use to ensure original requirements are met and defined constraints are controlled.
·Administers, through cutover planning and coordination with stakeholders, implementation of necessary business changes/additions to enterprise applications or integrated third party systems after testing is complete in order to ensure successful solution delivery.
·Develops, maintains, and provides technical subject matter expertise in order to convey and communicate capabilities, and delivers knowledge transfer to appropriate personnel for skill development.
Qualifications:
Project Management principles and techniques.
· System Development Lifecycle methodologies, processes and documentation.
· Testing approaches and documentation; including plans and scripts for unit, integration, system, and regression testing and/or system validation: installation, operational, and performance qualification for GxP systems.
· Cost estimation of a project from design, development, and testing to implementation, deployment and support for the required solution.
· Training design and roll-out.
· Key directional trends and emerging technologies in the IT industry.
· Report writing tools and technologies as applicable.
· Integration points with other platforms and third-party software.
· Security in enterprise software. Researching, evaluating and analyzing business requirements and new computer system methods, applications, procedures, and techniques.
· Analyzing problems, identifying alternative solutions, recommending and implementing systems, and/or enhancements for problem resolution.
· Writing and executing test scripts along with converting system data.
Utilizing project management tools and techniques to plan and ensure the progress and ultimate completion of designated projects; effectively manage time and resources to ensure that work is completed efficiently.
· In-depth (7 plus years) knowledge of HCM processes in the following functional areas is a must: Benefits & Compensation, Absence Management, Staffing/Employee Life-Cycle Management, ESS/MSS, Performance Management, Succession Planning, Benefits Network, Payroll Integration, etc.
· Strong (7 plus years) working knowledge, skills and experience in enterprise HCM systems such as SAP HCM, PeopleSoft HCM, etc., is a must. Workday HCM with experience developing integrations with PICOF/Studio, is required · Experience in partnering with HR business process owners to gather requirements, design/improvise HCM business processes, configure and unit test HCM system functionality, provide functional specifications and data maps to developers for new HCM reports, interfaces, and enhancements, and perform end-to-end integration testing of HCM business scenarios, is a must.
·Experience in interacting with external benefit providers to implement new interfaces or solve problems, is a must. Ability to troubleshoot and resolve issues related to interfaces from enterprise HCM system to external systems and benefit providers and internal systems.
· Experience with coordinating upgrades / regression testing of enterprise HCM systems is highly desired.
· Experience with using reporting tools in enterprise HCM systems to develop adhoc reports/queries is highly desired.
Bachelor's degree in related field from an accredited college or university, and seven (7) to ten (10) years enterprise system experience, with at least two (2) at a management level preferred; or an equivalent combination of education and experience.
Ray Lancaster
908-526-5440908-526-5440
RFL@Lancasterinc.net
http://www.lancasterassociates.net/
must have Studio and technical integration experience
$120k+15%+options
Business Systems Analyst III (Workday)
Oversees cross-functional teams tasked with solving business issues which require a technical solution providing subject matter expertise with regards to system functionality and capabilities for stakeholders.
·Participates in strategic meetings to review, evaluate, and/or propose new business opportunities through the implementation/enhancement of technical solutions, which are intended to improve customer relationships, operating efficiencies, and/or add business benefits.
·Identifies detailed requirements from business users through interviews, documentation, and facilitated working sessions for approved projects and enhancements.
·Partners with stakeholders and business representatives to identify necessary department resources to meet defined objectives.
·Leads team in analyzing information and prioritizing requirements to gain an understanding of the business needs in order to provide recommendations for solutions. Evaluates relative feedback and ROI to effectively align projects.
·Manages work plans, timelines, and budgets. Assesses project impacts through consultation with the business, management, regulatory, IT, quality assurance, validation, and training teams.
·Creates comprehensive business process models and maps based on requirements, capturing pertinent process step details in design documents so that opportunities for process improvements, benchmarks, key performance indicators, current metrics, and target objectives can be recognized establishing benefits realization objectives.
·Structures and develops test plans (e.g. test objectives, test cases, test data and test scripts) for executing unit, integration, system and/or acceptance testing in order to ensure the solution meets the business requirements.
·Manages acceptance testing with the business users performing system configuration and integration testing including the functionality, performance, and fit-for-use to ensure original requirements are met and defined constraints are controlled.
·Administers, through cutover planning and coordination with stakeholders, implementation of necessary business changes/additions to enterprise applications or integrated third party systems after testing is complete in order to ensure successful solution delivery.
·Develops, maintains, and provides technical subject matter expertise in order to convey and communicate capabilities, and delivers knowledge transfer to appropriate personnel for skill development.
Qualifications:
Project Management principles and techniques.
· System Development Lifecycle methodologies, processes and documentation.
· Testing approaches and documentation; including plans and scripts for unit, integration, system, and regression testing and/or system validation: installation, operational, and performance qualification for GxP systems.
· Cost estimation of a project from design, development, and testing to implementation, deployment and support for the required solution.
· Training design and roll-out.
· Key directional trends and emerging technologies in the IT industry.
· Report writing tools and technologies as applicable.
· Integration points with other platforms and third-party software.
· Security in enterprise software. Researching, evaluating and analyzing business requirements and new computer system methods, applications, procedures, and techniques.
· Analyzing problems, identifying alternative solutions, recommending and implementing systems, and/or enhancements for problem resolution.
· Writing and executing test scripts along with converting system data.
Utilizing project management tools and techniques to plan and ensure the progress and ultimate completion of designated projects; effectively manage time and resources to ensure that work is completed efficiently.
· In-depth (7 plus years) knowledge of HCM processes in the following functional areas is a must: Benefits & Compensation, Absence Management, Staffing/Employee Life-Cycle Management, ESS/MSS, Performance Management, Succession Planning, Benefits Network, Payroll Integration, etc.
· Strong (7 plus years) working knowledge, skills and experience in enterprise HCM systems such as SAP HCM, PeopleSoft HCM, etc., is a must. Workday HCM with experience developing integrations with PICOF/Studio, is required · Experience in partnering with HR business process owners to gather requirements, design/improvise HCM business processes, configure and unit test HCM system functionality, provide functional specifications and data maps to developers for new HCM reports, interfaces, and enhancements, and perform end-to-end integration testing of HCM business scenarios, is a must.
·Experience in interacting with external benefit providers to implement new interfaces or solve problems, is a must. Ability to troubleshoot and resolve issues related to interfaces from enterprise HCM system to external systems and benefit providers and internal systems.
· Experience with coordinating upgrades / regression testing of enterprise HCM systems is highly desired.
· Experience with using reporting tools in enterprise HCM systems to develop adhoc reports/queries is highly desired.
Bachelor's degree in related field from an accredited college or university, and seven (7) to ten (10) years enterprise system experience, with at least two (2) at a management level preferred; or an equivalent combination of education and experience.
Ray Lancaster
908-526-5440908-526-5440
RFL@Lancasterinc.net
http://www.lancasterassociates.net/
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