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Posted : Saturday, July 13, 2024 05:01 PM
*Job Title: HIM Director*
*Location: Oakland*
*Top Skill:*
*The HM is looking for candidates having exp around the following pointers.
* * *Clinical Trials* * *IRB* * *Regulatory* * *Quality knowledge* * *Healthcare exp* *● Certification in regulatory affairs, quality assurance or clinical research; ASQ (American * *● Society for Quality) Certification is preferred * *● Experience with on-site monitoring * *● Expert planning and organization skills * *● Strong attention to detail * *● Exceptionally team focused; actively contributes to a positive and innovative work environment * *● Able to demonstrate the highest ethical standards; promotes trust, respect and integrity * *● Spanish language skills a plus * Job Description ● Providing regulatory and quality consultation as a subject matter expert ● Provides both Regulatory and Quality training to Investigators, CTP team members, and at large training.
● Understanding regional, provincial, and federal laws that apply to the KPNC region.
● Writing clear, informative reports that highlight the main findings.
● Discussing quality standards and how to accomplish them with other employees.
● Understanding customer needs and requirements to develop effective quality control processes.
● Submitting reports and communicating with IRB and regulatory agencies ● Staying abreast of developments in GCP and federal regulations regarding clinical research.
● Assisting with QC and QA of various study related regulatory documents and reports.
● Assisting with training and mentoring of junior regulatory specialists and departmental QC and QA activities ● Ensures quality management system requirements are effectively established and it is maintained per GCP and Human Subject Protection standard regulations.
● Leads the development and execution of quality policy, objectives, and strategic plans.
● Directs and oversees all Quality Systems staff and functions in areas including FDA and ICH regulations and guidelines, document control, management review, corrective and preventive actions (CAPA), deviations, change control, internal audits, employee training, supplier management, risk management activities, application validation documentation, surveillance and complaints.
● Serves as lead contact for inspections by regulatory agencies and sponsor audits.
● Develops, reviews, strengthens, and approves all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs.
● Develops, plans, and leads readiness for inspections and audits at CTP by GCP and GxP regulatory authorities, clinical investigator sites, and contract organizations.
● Conducts data auditing and review in support of regulatory submissions and periodic safety reports.
● Chairs and coordinates quality management review meetings and oversees action items.
● Ensures completion of all corrective actions associated with the quality system and ensures that the CAPA process is compliant with regulatory requirements.
● Ensures all deviations are investigated, closed, tracked, trended, and checked for Effectiveness.
● Leads in developing CTP staff with a set of tools and training to conduct effective root cause analysis ● Reports quality compliance metrics to CTP officers and provides recommendations for improvements.
● Oversees and performs audit processes, including managing audit resources, tracking status of audit findings to closure, and audit record retention.
● Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries ● Performs other duties as related to providing quality program direction and to the mission, goals, and values of CTP.
Required Qualifications: ● Bachelor's degree with additional 10 years of progressively responsible experience ● managing quality compliance/assurance functions.
Masters' degree may substitute for ● two years of experience ● Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines ● Minimum five years in a quality management role with direct reports ● In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and ● experience with Quality Management Systems ● Demonstrated experience identifying areas for improvement and implementing solutions; ● ensuring compliance with standards, regulations and company procedures; and ● administering successful programs within appropriate timelines ● Experience conducting training for quality assurance and/or regulatory affairs ● Ability to interact positively with all levels of staff and external contacts ● Proficiency in Microsoft Word, Outlook, Excel and PowerPoint ● Excellent verbal and written communication skills ● Experience adopting a flexible, proactive, and service-oriented approach ● Travel may be required Job Type: Contract Salary: $55.
00 - $95.
00 per hour Schedule: * 8 hour shift Ability to Relocate: * Quincy, CA 95971: Relocate before starting work (Required) Work Location: In person
* * *Clinical Trials* * *IRB* * *Regulatory* * *Quality knowledge* * *Healthcare exp* *● Certification in regulatory affairs, quality assurance or clinical research; ASQ (American * *● Society for Quality) Certification is preferred * *● Experience with on-site monitoring * *● Expert planning and organization skills * *● Strong attention to detail * *● Exceptionally team focused; actively contributes to a positive and innovative work environment * *● Able to demonstrate the highest ethical standards; promotes trust, respect and integrity * *● Spanish language skills a plus * Job Description ● Providing regulatory and quality consultation as a subject matter expert ● Provides both Regulatory and Quality training to Investigators, CTP team members, and at large training.
● Understanding regional, provincial, and federal laws that apply to the KPNC region.
● Writing clear, informative reports that highlight the main findings.
● Discussing quality standards and how to accomplish them with other employees.
● Understanding customer needs and requirements to develop effective quality control processes.
● Submitting reports and communicating with IRB and regulatory agencies ● Staying abreast of developments in GCP and federal regulations regarding clinical research.
● Assisting with QC and QA of various study related regulatory documents and reports.
● Assisting with training and mentoring of junior regulatory specialists and departmental QC and QA activities ● Ensures quality management system requirements are effectively established and it is maintained per GCP and Human Subject Protection standard regulations.
● Leads the development and execution of quality policy, objectives, and strategic plans.
● Directs and oversees all Quality Systems staff and functions in areas including FDA and ICH regulations and guidelines, document control, management review, corrective and preventive actions (CAPA), deviations, change control, internal audits, employee training, supplier management, risk management activities, application validation documentation, surveillance and complaints.
● Serves as lead contact for inspections by regulatory agencies and sponsor audits.
● Develops, reviews, strengthens, and approves all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs.
● Develops, plans, and leads readiness for inspections and audits at CTP by GCP and GxP regulatory authorities, clinical investigator sites, and contract organizations.
● Conducts data auditing and review in support of regulatory submissions and periodic safety reports.
● Chairs and coordinates quality management review meetings and oversees action items.
● Ensures completion of all corrective actions associated with the quality system and ensures that the CAPA process is compliant with regulatory requirements.
● Ensures all deviations are investigated, closed, tracked, trended, and checked for Effectiveness.
● Leads in developing CTP staff with a set of tools and training to conduct effective root cause analysis ● Reports quality compliance metrics to CTP officers and provides recommendations for improvements.
● Oversees and performs audit processes, including managing audit resources, tracking status of audit findings to closure, and audit record retention.
● Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries ● Performs other duties as related to providing quality program direction and to the mission, goals, and values of CTP.
Required Qualifications: ● Bachelor's degree with additional 10 years of progressively responsible experience ● managing quality compliance/assurance functions.
Masters' degree may substitute for ● two years of experience ● Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines ● Minimum five years in a quality management role with direct reports ● In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and ● experience with Quality Management Systems ● Demonstrated experience identifying areas for improvement and implementing solutions; ● ensuring compliance with standards, regulations and company procedures; and ● administering successful programs within appropriate timelines ● Experience conducting training for quality assurance and/or regulatory affairs ● Ability to interact positively with all levels of staff and external contacts ● Proficiency in Microsoft Word, Outlook, Excel and PowerPoint ● Excellent verbal and written communication skills ● Experience adopting a flexible, proactive, and service-oriented approach ● Travel may be required Job Type: Contract Salary: $55.
00 - $95.
00 per hour Schedule: * 8 hour shift Ability to Relocate: * Quincy, CA 95971: Relocate before starting work (Required) Work Location: In person
• Phone : NA
• Location : 4125 Oakland Camp Rd, Quincy, CA
• Post ID: 9133527338
