USA - Quality Compliance Specialist - Apolis
Cambridge, MA 02142
About the Job
APOLIS2024
Job title: Clinical Quality Compliance Lead
Location: 500 Kendall Street, Cambridge, MA 02142 (Hybrid role, 2 days per week on-site)
Duration- 12 months
Pay Rate $75.00-125.00/hour
Details -
OBJECTIVES/PURPOSE: Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations. Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Takeda s values and strategic priorities. Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.
Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified). Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.
Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively provides strategic and tactical directions in the mitigation. Hosts GCP inspections, and provides strategic direction to relevant functions and Subject Matter Experts (SME). Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management. Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and timebound CAPAs are developed. Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome. Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections. Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc). Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quality Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development. Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management. Leads cross-functional continual improvements projects that enable a compliant quality systems in the clinical trial delivery quality systems. Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered. Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance. Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs). Contributes to any relevant quality and compliance governance in Takeda, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.
Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures Lead and/or support quality governance council meetings Liaise and collaborate with internal Takeda and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives Analyse, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation. Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities. Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution Lead process improvement initiatives as requested by management Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.) BSc in a scientific or allied health/medical field (or equivalent degree). Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives. Skilled in managing global, cross-functional projects. Fluency in written and spoken English, additional language skills a plus.
BA/BS degree required; Advanced Degree preferred. Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry. Minimum 7 years of GCP-related Quality Assurance experience. Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development. Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems. Strong technical writing skills; able to write quality positions, audit reports, and procedures. Excellent communication skills with ability to negotiate and influence without authority in a matrix environment. Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines. Superior attention to detail and ability to analyse complex data.
LICENSES/CERTIFICATIONS: GCP Quality Assurance registration/certification preferred.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position). Routine demands of an office-based environment.
TRAVEL REQUIREMENTS: Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required. Requires approximately 30% travel
Job title: Clinical Quality Compliance Lead
Location: 500 Kendall Street, Cambridge, MA 02142 (Hybrid role, 2 days per week on-site)
Duration- 12 months
Pay Rate $75.00-125.00/hour
Details -
OBJECTIVES/PURPOSE: Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations. Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Takeda s values and strategic priorities. Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.
Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified). Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.
Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively provides strategic and tactical directions in the mitigation. Hosts GCP inspections, and provides strategic direction to relevant functions and Subject Matter Experts (SME). Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management. Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and timebound CAPAs are developed. Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome. Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections. Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc). Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quality Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development. Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management. Leads cross-functional continual improvements projects that enable a compliant quality systems in the clinical trial delivery quality systems. Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered. Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance. Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs). Contributes to any relevant quality and compliance governance in Takeda, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.
Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures Lead and/or support quality governance council meetings Liaise and collaborate with internal Takeda and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives Analyse, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation. Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities. Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution Lead process improvement initiatives as requested by management Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.) BSc in a scientific or allied health/medical field (or equivalent degree). Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives. Skilled in managing global, cross-functional projects. Fluency in written and spoken English, additional language skills a plus.
BA/BS degree required; Advanced Degree preferred. Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry. Minimum 7 years of GCP-related Quality Assurance experience. Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development. Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems. Strong technical writing skills; able to write quality positions, audit reports, and procedures. Excellent communication skills with ability to negotiate and influence without authority in a matrix environment. Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines. Superior attention to detail and ability to analyse complex data.
LICENSES/CERTIFICATIONS: GCP Quality Assurance registration/certification preferred.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position). Routine demands of an office-based environment.
TRAVEL REQUIREMENTS: Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required. Requires approximately 30% travel
Source : Apolis