What are the responsibilities and job description for the Manager, Systems & Validation position at ICON Strategic Solutions?
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Under the direction of the Head, Data Systems QA, the primary responsibility of the Data Systems QA & Compliance Specialist will be to support the R&D Quality Compliance & Systems function by providing QA&C support of computer system validation (CSV) activities in Research & Development. The Data Systems QA & Compliance Specialist will assure compliance with applicable GxP regulations and standards (SDLC); advising the R&D IT Business Partner and R&D system owners/management on risk-related matters pertaining to R&D systems; and conducting audits to identify overall trends and areas of risk for systems in use within R&D as well as those externally in use by R&D service providers.
Key responsibilities for this role are to provide professional expertise and guidance in applicable regulations (e.g., 21 CFR Part 11, Annex 11, and ICH E6(R2)) and industry standards (e.g., ISPE GAMP 5) as applicable to R&D GxP environment (GCP, GLP, GVP, GDP). Additional duties include but not limited to liaising with various internal R&D functions, IT, and contract auditors and assisting stakeholders in maintaining systems within a state of compliance while providing recommendations for process improvement.
**Delivery of Validation Support**
Leads by determining the appropriate level of validation to be applied for new and existing R&D systems and resulting CSV deliverables.
Facilitates the R&D QA&C support of the R&D IT Business Partner and R&D system owner initiatives as a member of a project team for the implementation of new systems or major upgrades to existing systems.
Reviews and or approves validation deliverables/documentation during the validation process (e.g., validation plans, user requirements, functional specifications, installation qualification, operational qualification, user acceptance testing, traceability matrices and validation summary reports).
Reviews and approves proposed changes to GxP R&D systems and determines the necessary
**Audit Oversight/Conduct**
Assists in the planning and execution of CSV-related audit activities associated with external application providers, external service providers, and internal systems with related processes. Leads and conducts audits in collaboration with appropriate SMEs and oversees the need for the prioritization and timely completion of identified audits.
Supports the delivery, review and approval of audit reports, generated from within Data Systems QA or by contract auditors.
Collaboratively works with key stakeholders from R&D and IT to ensure the optimal audit scope planning as well as ensuring appropriate corrective and preventive actions are completed in a timely manner.
**Management / Strategy**
Assists in managing key components of the CSV program as directed by management. Provides regular consultation to various the R&D Business Partner and R&D stakeholders on CSV related matters.
Assists with Quality Agreements and Service Level Agreements with external and internal parties respectively.
Assists in delivering periodic training to stakeholders on topics related to system compliance, 21 CFR Part 11, and best practices.
Provides support in harmonizing standards for the SDLC. Produces management status reports for areas of responsibility.
**Regulatory Agency Support**
Assists with the development and management of the strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections, inspections and investigator site audit inspections for assigned programs.
Assist in hosting regulatory inspections, as needed
Provide input and support to the Quality Operations team, as needed.
**Key Skills, Abilities, and Competencies**
Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA and MHRA.
• Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5).
Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.
Supports a culture of compliance while encouraging a culture of innovation.
Strong knowledge and expertise in audit fundamentals and managing audit programs.
**Leadership & Interpersonal Skills**
Strong leadership skills with the ability to motivate and inspire colleagues, with tact and diplomacy.
Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems.
A self-starter, who is able to define, prioritize and manage tasks within a project.
Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity. Ability to think strategically.
Strong judgment and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Sponsor.
**Communication Skills**
Strong communication and technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs. Strong attention to detail with the ability to articulate quality related risks and potential impact
Requires a high degree of problem solving ability; understanding objectives and processes across IT and R&D functions; and implores solid judgment to determine when management escalation is necessary.
Mature, problem solving attitude, exhibits judgment and realistic understanding of the issues; able to use reason even when dealing with emotional topics and have the interpersonal skills to deliver tough messages.
Bachelor's degree required with a life science focus preferred; Masters Degree in management or scientific discipline a plus
At least 10 years of pharmaceutical experience. 6 years of validation and or audit program management
Ideal candidate will have broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena (ideally within the clinical and/or non-clinical areas), the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements.
Strong knowledge of MSWord, Excel, PowerPoint, SharePoint, & Outlook
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Under the direction of the Head, Data Systems QA, the primary responsibility of the Data Systems QA & Compliance Specialist will be to support the R&D Quality Compliance & Systems function by providing QA&C support of computer system validation (CSV) activities in Research & Development. The Data Systems QA & Compliance Specialist will assure compliance with applicable GxP regulations and standards (SDLC); advising the R&D IT Business Partner and R&D system owners/management on risk-related matters pertaining to R&D systems; and conducting audits to identify overall trends and areas of risk for systems in use within R&D as well as those externally in use by R&D service providers.
Key responsibilities for this role are to provide professional expertise and guidance in applicable regulations (e.g., 21 CFR Part 11, Annex 11, and ICH E6(R2)) and industry standards (e.g., ISPE GAMP 5) as applicable to R&D GxP environment (GCP, GLP, GVP, GDP). Additional duties include but not limited to liaising with various internal R&D functions, IT, and contract auditors and assisting stakeholders in maintaining systems within a state of compliance while providing recommendations for process improvement.
**Delivery of Validation Support**
Leads by determining the appropriate level of validation to be applied for new and existing R&D systems and resulting CSV deliverables.
Facilitates the R&D QA&C support of the R&D IT Business Partner and R&D system owner initiatives as a member of a project team for the implementation of new systems or major upgrades to existing systems.
Reviews and or approves validation deliverables/documentation during the validation process (e.g., validation plans, user requirements, functional specifications, installation qualification, operational qualification, user acceptance testing, traceability matrices and validation summary reports).
Reviews and approves proposed changes to GxP R&D systems and determines the necessary
**Audit Oversight/Conduct**
Assists in the planning and execution of CSV-related audit activities associated with external application providers, external service providers, and internal systems with related processes. Leads and conducts audits in collaboration with appropriate SMEs and oversees the need for the prioritization and timely completion of identified audits.
Supports the delivery, review and approval of audit reports, generated from within Data Systems QA or by contract auditors.
Collaboratively works with key stakeholders from R&D and IT to ensure the optimal audit scope planning as well as ensuring appropriate corrective and preventive actions are completed in a timely manner.
**Management / Strategy**
Assists in managing key components of the CSV program as directed by management. Provides regular consultation to various the R&D Business Partner and R&D stakeholders on CSV related matters.
Assists with Quality Agreements and Service Level Agreements with external and internal parties respectively.
Assists in delivering periodic training to stakeholders on topics related to system compliance, 21 CFR Part 11, and best practices.
Provides support in harmonizing standards for the SDLC. Produces management status reports for areas of responsibility.
**Regulatory Agency Support**
Assists with the development and management of the strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections, inspections and investigator site audit inspections for assigned programs.
Assist in hosting regulatory inspections, as needed
Provide input and support to the Quality Operations team, as needed.
**Key Skills, Abilities, and Competencies**
Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA and MHRA.
• Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5).
Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.
Supports a culture of compliance while encouraging a culture of innovation.
Strong knowledge and expertise in audit fundamentals and managing audit programs.
**Leadership & Interpersonal Skills**
Strong leadership skills with the ability to motivate and inspire colleagues, with tact and diplomacy.
Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems.
A self-starter, who is able to define, prioritize and manage tasks within a project.
Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity. Ability to think strategically.
Strong judgment and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Sponsor.
**Communication Skills**
Strong communication and technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs. Strong attention to detail with the ability to articulate quality related risks and potential impact
Requires a high degree of problem solving ability; understanding objectives and processes across IT and R&D functions; and implores solid judgment to determine when management escalation is necessary.
Mature, problem solving attitude, exhibits judgment and realistic understanding of the issues; able to use reason even when dealing with emotional topics and have the interpersonal skills to deliver tough messages.
Bachelor's degree required with a life science focus preferred; Masters Degree in management or scientific discipline a plus
At least 10 years of pharmaceutical experience. 6 years of validation and or audit program management
Ideal candidate will have broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena (ideally within the clinical and/or non-clinical areas), the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements.
Strong knowledge of MSWord, Excel, PowerPoint, SharePoint, & Outlook
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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