BioSpace
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Company Description The AbbVie mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie works across immunology, oncology, neuroscience, and eye care, including products and services in the Allergan Aesthetics portfolio. For more information, visit www.abbvie.com. Follow @abbvie on social media.
Job Description
Purpose:
The Director of Pharmacovigilance Auditing is responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure AbbVie\'s Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Audit management includes auditing, people leadership/development and compliance reporting where required.
This role will ensure that R&D remains in compliance with corporate policies and applicable worldwide regulations. The role includes strategic leadership of Audit Programs to assure compliance, external audit of AbbVie and inspection readiness across the scope of our Portfolio, global footprint and the foundational connections of our complex PV System. Provide consistent and aligned consultation to R&D leadership stakeholders from multi-functional interactions with a focus on audit management, risk decisions, metric/process reporting with a data-driven, comprehensive quality perspective. Influencing decision-making to drive foundational quality requirements into process, issue and risk management and inclusion within process improvement initiatives.
This position is accountable to the leader of the Internal Audit function for R&D Quality. The decisions and recommendations made by the individual will directly assess the controls in place and will impact actions ensuring adherence to applicable regulations and thereby promote the continued success of R&D. Core competencies include quality management, audit program management, strategic and dynamic team leadership, critical communication skills, functional expertise and analytical aptitude.
Responsibilities
Lead collaboration across R&D Quality, Safety and core PV System stakeholders to ensure the audit landscape is well characterized, risks to the PV System are routinely assessed for compliance and quality with audit methodology applied at strategic and tactical levels.
Lead cross-discipline projects and implement strategies that benefit the PV System quality foundation, enabling strategic growth of the audit team via data and advanced technology to drive decision making and audit execution.
Monitor new regulations and industry trends; ensure compliance with regulations and policies within AbbVie and in partnership with external collaborations as applicable.
Identify and manage support of operational and strategic issues within the audit program with governance and escalation strategies as appropriate.
Lead the curation and maintenance of inspection-ready documentation (SOPs and evidence of execution) to assure any team member supporting Health Authority interactions can present the PV Audit function.
Oversee the timely and comprehensive provision of required data to ensure the Product Safety Master File contains accurate audit-related data.
Lead routine interactions with stakeholder leadership across audited functions to ensure understanding of audit targets, areas for improvement, program changes and performance of the audit team and auditees.
Lead risk management practices tailored to the assigned audit program, linking to R&D Quality, Compliance and External Partnership leaders to drive improvements and forward-looking strategies for audit priorities.
Build a strategic, high-performing team executing audits, identifying and helping prevent risks impacting on-market and development milestones, while increasing success during external audits and inspections.
Identify, monitor and improve audit organization connections and utilization of critical Quality System Elements including Risk Management, Change Management and Exception Management.
Engage stakeholders in ongoing reviews of activities, issues and achievements related to audit performance by auditees; build forums to ensure QA involvement for process improvements and proactive QA activities.
Recruit, develop, manage and mentor a team of Quality Professionals, including defining goals and development plans; provide annual performance reviews and make staffing recommendations.
The role can be remote within the US or UK. Title and grading to be adapted to the host country; compensation will be to your country of residence.
Qualifications
Bachelor degree in a physical science, life science, nursing, pharmacy or equivalent experience required.
10+ years of pharmaceutical industry experience.
Pharmacovigilance experience.
3+ years of people leadership experience, highly preferred.
Strong people leadership and team management skills with the ability to mentor, coach, and develop high-performing audit professionals and teams.
Ability to balance adaptability with consistent and timely decision making to ensure delivery of core audit programs while leveraging people, processes and technology.
Ability to lead, prioritize and resource plan for multiple, complex, competing quality improvement projects and activities.
Ability to lead with a change-ready mindset and cultivate a team who delivers process improvement, accountability and trust as a strategic advantage for R&D Quality.
Additional Information
Applicable to applicants in locations with pay disclosure requirements under state or local law: compensation ranges described are base pay ranges believed to be appropriate for the role at the time of posting; actual pay will depend on geographic location and may vary.
Comprehensive benefits package includes paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
Note: The compensation and benefits described are subject to company discretion and applicable law.
AbbVie is an equal opportunity employer and is committed to diversity and inclusion. EEO statements apply.
US & Puerto Rico candidates: learn more about equal employment opportunity and reasonable accommodations at the provided links.
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
Industries: Internet News
Referrals increase your chances of interviewing at BioSpace.
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Company Description The AbbVie mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie works across immunology, oncology, neuroscience, and eye care, including products and services in the Allergan Aesthetics portfolio. For more information, visit www.abbvie.com. Follow @abbvie on social media.
Job Description
Purpose:
The Director of Pharmacovigilance Auditing is responsible for implementing a comprehensive audit program and leading a high-performing team of audit staff to assure AbbVie\'s Pharmacovigilance (PV) system has proper quality, integrity and controls via strategic audit oversight. Audit management includes auditing, people leadership/development and compliance reporting where required.
This role will ensure that R&D remains in compliance with corporate policies and applicable worldwide regulations. The role includes strategic leadership of Audit Programs to assure compliance, external audit of AbbVie and inspection readiness across the scope of our Portfolio, global footprint and the foundational connections of our complex PV System. Provide consistent and aligned consultation to R&D leadership stakeholders from multi-functional interactions with a focus on audit management, risk decisions, metric/process reporting with a data-driven, comprehensive quality perspective. Influencing decision-making to drive foundational quality requirements into process, issue and risk management and inclusion within process improvement initiatives.
This position is accountable to the leader of the Internal Audit function for R&D Quality. The decisions and recommendations made by the individual will directly assess the controls in place and will impact actions ensuring adherence to applicable regulations and thereby promote the continued success of R&D. Core competencies include quality management, audit program management, strategic and dynamic team leadership, critical communication skills, functional expertise and analytical aptitude.
Responsibilities
Lead collaboration across R&D Quality, Safety and core PV System stakeholders to ensure the audit landscape is well characterized, risks to the PV System are routinely assessed for compliance and quality with audit methodology applied at strategic and tactical levels.
Lead cross-discipline projects and implement strategies that benefit the PV System quality foundation, enabling strategic growth of the audit team via data and advanced technology to drive decision making and audit execution.
Monitor new regulations and industry trends; ensure compliance with regulations and policies within AbbVie and in partnership with external collaborations as applicable.
Identify and manage support of operational and strategic issues within the audit program with governance and escalation strategies as appropriate.
Lead the curation and maintenance of inspection-ready documentation (SOPs and evidence of execution) to assure any team member supporting Health Authority interactions can present the PV Audit function.
Oversee the timely and comprehensive provision of required data to ensure the Product Safety Master File contains accurate audit-related data.
Lead routine interactions with stakeholder leadership across audited functions to ensure understanding of audit targets, areas for improvement, program changes and performance of the audit team and auditees.
Lead risk management practices tailored to the assigned audit program, linking to R&D Quality, Compliance and External Partnership leaders to drive improvements and forward-looking strategies for audit priorities.
Build a strategic, high-performing team executing audits, identifying and helping prevent risks impacting on-market and development milestones, while increasing success during external audits and inspections.
Identify, monitor and improve audit organization connections and utilization of critical Quality System Elements including Risk Management, Change Management and Exception Management.
Engage stakeholders in ongoing reviews of activities, issues and achievements related to audit performance by auditees; build forums to ensure QA involvement for process improvements and proactive QA activities.
Recruit, develop, manage and mentor a team of Quality Professionals, including defining goals and development plans; provide annual performance reviews and make staffing recommendations.
The role can be remote within the US or UK. Title and grading to be adapted to the host country; compensation will be to your country of residence.
Qualifications
Bachelor degree in a physical science, life science, nursing, pharmacy or equivalent experience required.
10+ years of pharmaceutical industry experience.
Pharmacovigilance experience.
3+ years of people leadership experience, highly preferred.
Strong people leadership and team management skills with the ability to mentor, coach, and develop high-performing audit professionals and teams.
Ability to balance adaptability with consistent and timely decision making to ensure delivery of core audit programs while leveraging people, processes and technology.
Ability to lead, prioritize and resource plan for multiple, complex, competing quality improvement projects and activities.
Ability to lead with a change-ready mindset and cultivate a team who delivers process improvement, accountability and trust as a strategic advantage for R&D Quality.
Additional Information
Applicable to applicants in locations with pay disclosure requirements under state or local law: compensation ranges described are base pay ranges believed to be appropriate for the role at the time of posting; actual pay will depend on geographic location and may vary.
Comprehensive benefits package includes paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
Note: The compensation and benefits described are subject to company discretion and applicable law.
AbbVie is an equal opportunity employer and is committed to diversity and inclusion. EEO statements apply.
US & Puerto Rico candidates: learn more about equal employment opportunity and reasonable accommodations at the provided links.
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
Industries: Internet News
Referrals increase your chances of interviewing at BioSpace.
#J-18808-Ljbffr