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Job Details

Associate Director GxP Audit Strategy amp Operations

Location
New Brunswick, NJ

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Job Description:
ASSOCIATE DIRECTOR GxP IT QUALITY ASSURANCE (GxP ITQA Audit Operations)
Global Quality Functional Area Description
Global Quality GxP Information Technology Quality Assurance (GQ GxP-ITQA) ensures all GXP computerized systems across the end-to-end product lifecycle meet BMS standards and global regulatory authority requirements and expectations.
Principal Objective of the Position
Establish, lead and manage an effective and knowledgeable computer systems audit strategy and operations tower within the Global Quality GxP IT Quality Assurance organization with specialization in providing oversight for the management of electronic records and/or electronic signatures in compliance with world-wide health authority regulations through independent audits and assessments.
Key Responsibilities and Major Duties
Management of departmental activities
• Provide management oversight of activities associated with an independent GxP audit program for internal and external GPS and R&D computerized systems across the end-to-end product lifecycle (GPS and R&D) including strategy, planning, execution, reporting and observation follow-up. Includes internal and external (vendor and/or contract service provider) audits.
• Recruit and train staff to carry out all functions of the GQ GxP-ITQA Audit Operations and Strategy tower. Routinely review the performance of direct reports with regard to the achievement of goals, objectives and BMS Core Behaviors.
• Review and/or approve appropriate BMS policies, directives and procedures in alignment with relevant governmental regulations and guidelines.
General Activities
• Lead the execution of 3 year audit plans and schedules based on informed risk and in collaboration with other GxP audit functions with Global Quality and Global Internal Audit.
• Plan, organize, execute and document audits of regulated computerized systems and related operations and IT controls. The audits are intended to assess compliance with appropriate regulations, guidances and company procedures and help to assure the quality and integrity of the data collected from these systems. Includes internal and external (vendor and/or contract service provider) audits
• Utilize a risk-based approach in the development of audit scope with focus on critical IT controls impacting patient safety, product quality and data integrity
• Both peer review and/or prepare clear, concise, accurate and evidence-based audit reports to effectively communicate audit findings and recommended corrective action to management. Discern significant audit issues and identify appropriate recommendations. Review and assess corrective and preventive action plans according to specified timelines to assure resolution of audit findings and prevent re-occurrence. Maintain detailed documentation supporting the audit
• Maintain an in-depth knowledge of governmental regulations which impact the development and use of computer systems as well as relevant BMS policies and procedures
• Analyze documentation, process information, technical configurations, or other client provided information and document the results of conversations and analysis
• Research new technologies, understand existing processes, and reference recognized standards and frameworks
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned
• Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education
• Identify opportunities for continuous improvement
• Manage tower operational expenses in alignment with allocated budget
• Manage alignment and allocation of resources to ensure adequate and timely regulatory compliance support.
• Adherence to BMS core behaviors
Meeting Participation
• Lead GQ GxP-ITQA Audit Operations and Strategy tower meetings
• Attend GQ GxP-ITQA departmental meetings
• Interface meetings with functional areas supported
• Departmental meetings and senior management meetings
• Audit Community of Practice forums
Key Stakeholders/Contacts
• Head of the GQ GxP ITQA organization
• Direct reports
• Other members of GQ GxP-ITQA and department management.
• Management and staff from the GPS and R&D departments involved in GxP regulated operations
• Staff directly responsible for the business operations of computerized systems
• Information Technology staff at commensurate levels of the organizations including but not limited to:
o Information Security
o Validation Services
o Service and Provider Quality Management
o Hosting Services
o Contracted Enterprise Service Providers
• Management of the associated quality departments
Summary of Qualifications
Education:
• University Graduate; BA/BS Life-Sciences degree preferred.
Experience:
• Advanced auditing skills (minimum 10 years) as a Lead Auditor with demonstrated aptitude for auditing Information Systems and associated controls used by pharmaceutical companies, their associated CROs, vendors or service providers.
• Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 5 years experience).
• Minimum of 5 years managing people
Key Competencies – knowledge, skills, abilities, other
• Advanced audit skills across the end-to-end product development life cycle (GPS and R&D).
• Previous experience in risk-based approach to auditing and computerized system validation a plus. Understanding of quality risk-management concepts (ICH Q9) preferred
• Ability to write audit observations clearly and concisely is a must. Writing samples are required.
• Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
• Experience with Trackwise or similar quality management systems preferred.
• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required.
• Must understand general computing and data integrity controls
• Must understand industry accepted software development and validation life cycle programs.
• Must have staff management experience, responsible for department(s), planning, budgeting and performance audits.
• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Able to work effectively with multicultural workforce.
• Excellent team player attitude.
• Ability to manage competing priorities
Working Conditions
Travel Required (nature and frequency) About 25% travel to meet with stakeholders, attend professional meetings and seminars and to attend audit meetings
Apply Now
ASSOCIATE DIRECTOR GxP IT QUALITY ASSURANCE (GxP ITQA Audit Operations)
Global Quality Functional Area Description
Global Quality GxP Information Technology Quality Assurance (GQ GxP-ITQA) ensures all GXP computerized systems across the end-to-end product lifecycle meet BMS standards and global regulatory authority requirements and expectations.
Principal Objective of the Position
Establish, lead and manage an effective and knowledgeable computer systems audit strategy and operations tower within the Global Quality GxP IT Quality Assurance organization with specialization in providing oversight for the management of electronic records and/or electronic signatures in compliance with world-wide health authority regulations through independent audits and assessments.
Key Responsibilities and Major Duties
Management of departmental activities
• Provide management oversight of activities associated with an independent GxP audit program for internal and external GPS and R&D computerized systems across the end-to-end product lifecycle (GPS and R&D) including strategy, planning, execution, reporting and observation follow-up. Includes internal and external (vendor and/or contract service provider) audits.
• Recruit and train staff to carry out all functions of the GQ GxP-ITQA Audit Operations and Strategy tower. Routinely review the performance of direct reports with regard to the achievement of goals, objectives and BMS Core Behaviors.
• Review and/or approve appropriate BMS policies, directives and procedures in alignment with relevant governmental regulations and guidelines.
General Activities
• Lead the execution of 3 year audit plans and schedules based on informed risk and in collaboration with other GxP audit functions with Global Quality and Global Internal Audit.
• Plan, organize, execute and document audits of regulated computerized systems and related operations and IT controls. The audits are intended to assess compliance with appropriate regulations, guidances and company procedures and help to assure the quality and integrity of the data collected from these systems. Includes internal and external (vendor and/or contract service provider) audits
• Utilize a risk-based approach in the development of audit scope with focus on critical IT controls impacting patient safety, product quality and data integrity
• Both peer review and/or prepare clear, concise, accurate and evidence-based audit reports to effectively communicate audit findings and recommended corrective action to management. Discern significant audit issues and identify appropriate recommendations. Review and assess corrective and preventive action plans according to specified timelines to assure resolution of audit findings and prevent re-occurrence. Maintain detailed documentation supporting the audit
• Maintain an in-depth knowledge of governmental regulations which impact the development and use of computer systems as well as relevant BMS policies and procedures
• Analyze documentation, process information, technical configurations, or other client provided information and document the results of conversations and analysis
• Research new technologies, understand existing processes, and reference recognized standards and frameworks
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned
• Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education
• Identify opportunities for continuous improvement
• Manage tower operational expenses in alignment with allocated budget
• Manage alignment and allocation of resources to ensure adequate and timely regulatory compliance support.
• Adherence to BMS core behaviors
Meeting Participation
• Lead GQ GxP-ITQA Audit Operations and Strategy tower meetings
• Attend GQ GxP-ITQA departmental meetings
• Interface meetings with functional areas supported
• Departmental meetings and senior management meetings
• Audit Community of Practice forums
Key Stakeholders/Contacts
• Head of the GQ GxP ITQA organization
• Direct reports
• Other members of GQ GxP-ITQA and department management.
• Management and staff from the GPS and R&D departments involved in GxP regulated operations
• Staff directly responsible for the business operations of computerized systems
• Information Technology staff at commensurate levels of the organizations including but not limited to:
o Information Security
o Validation Services
o Service and Provider Quality Management
o Hosting Services
o Contracted Enterprise Service Providers
• Management of the associated quality departments
Summary of Qualifications
Education:
• University Graduate; BA/BS Life-Sciences degree preferred. Experience:
• Advanced auditing skills (minimum 10 years) as a Lead Auditor with demonstrated aptitude for auditing Information Systems and associated controls used by pharmaceutical companies, their associated CROs, vendors or service providers.
• Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 5 years experience).
• Minimum of 5 years managing people
Key Competencies – knowledge, skills, abilities, other
• Advanced audit skills across the end-to-end product development life cycle (GPS and R&D).
• Previous experience in risk-based approach to auditing and computerized system validation a plus. Understanding of quality risk-management concepts (ICH Q9) preferred
• Ability to write audit observations clearly and concisely is a must. Writing samples are required.
• Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
• Experience with Trackwise or similar quality management systems preferred.
• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required.
• Must understand general computing and data integrity controls
• Must understand industry accepted software development and validation life cycle programs.
• Must have staff management experience, responsible for department(s), planning, budgeting and performance audits.
• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Able to work effectively with multicultural workforce.
• Excellent team player attitude.
• Ability to manage competing priorities
Working Conditions
Travel Required (nature and frequency) About 25% travel to meet with stakeholders, attend professional meetings and seminars and to attend audit meetings
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