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
908-526-5440
908-526-5440
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
908-526-5440
RFL@Lancasterinc.net
www.LancasterAssociates.net
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