Senior Manager, Clinical Quality Assurance - Americas

BioSpace; North Chicago (IL); Hybride; USD 140 000 - 200 000; Plein temps

Résumé du poste

AbbVie is seeking a RDQA AREA Senior Manager to lead quality assurance efforts across assigned countries and regions within the global development lifecycle. You will drive proactive quality management, uphold the One AbbVie Quality System, and ensure regulatory alignment for clinical research activities.

You will collaborate with clinical development leaders, manage inspections and audits, and mentor AREA staff to sustain continuous improvement in quality and compliance.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy, or other medical science degree with equivalent technical experience.
• 8+ years in biopharmaceutical/medical device quality assurance, compliance, regulatory affairs, clinical research or related development functions, including 3 years in a lead role.
• Strong understanding of local and global regulatory requirements and regulatory perspectives.
• Ability to maintain strategic risk focus amid evolving global regulations and expectations; agile and adaptable.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Motivates and influences others, including those without direct authority.
• Strong analytical skills with structured, concise communication.
• Ability to work at an experienced level, leading collaboration with partners at all levels.
• Excellent written & oral communication, presentation and influencing skills.
• Strong negotiation, influencing and cross-functional collaboration abilities.
• Ability to foster cross-functional teams across functions.

Responsabilités

• The RDQA AREA Senior Manager will provide support for the assigned countries and region and will be responsible for the implementation/execution of activities related to proactive quality management.
• Maintain a close, collaborative relationship with RDQA functions impacting clinical research.
• Establish collaborative working relationships with clinical development leaders to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
• Oversee quality and compliance in a regulated environment including AbbVie policies and procedures and country/regional standards.
• Lead and/or collaborate on risk identification and mitigation for clinical research activities including trials with periodic reviews of quality data for improvement.
• Establish quality measures to achieve RDQA goals and drive quality strategy in designated countries/region with RDQA AREA personnel.
• Manage governance/oversight that aligns with One AbbVie Quality System; identify trends, root causes, and mitigate risks.
• Ensure understanding of quality requirements within Affiliates; work with R&D management on health of Quality System, and identify issues.
• Maintain awareness of applicable regulations and develop standards to measure quality in assigned countries/region for clinical research.
• Support Necessary Supplier Visits, Audits And Vendor Qualifications
• Develop inspection strategy in collaboration with AREA Associate Director and provide inspection-readiness for local/regional Health Authority inspections.
• Provide oversight and follow-up for Health Authority inspections; participate as needed.
• Determine need for country/process assessments/audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits to assess compliance; communicate results; review and approve CAPA/audit responses.
• Support development of robust audit/inspection responses through coaching and education.
• Mentor AREA Managers/AREA Associates or line management as needed.

Connaissances

Regulatory compliance

Quality systems

Audit management

Formation

Bachelor's degree in Biology, Nursing, Pharmacy, or related medical science

Description du poste

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ

Purpose: As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve

product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D global trial footprint has been expanding due to growth in the pipeline and the complexity of global development resulting in an overall increase in global trials in the Affiliates. In addition, the acquisition of Allergan and integration with AbbVie have significantly increased clinical trials managed from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical development/R&D enterprise within designated countries around the world.

AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie. The expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and objectives for submission of new therapies including but not limited to adherence to One AbbVie Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve first pass approvals thereby advancing the pipeline.

This position will report to RDQA Associate Director or RDQA Global Director, AREA

Major Responsibilities

The RDQA AREA Senior Manager will provide support for the assigned countries and region and will

be responsible for the implementation/execution of activities related to proactive quality

Management. The Following Are Key Responsibilities

• Maintain a close, collaborative relationship with RDQA functions impacting clinical research
• Establish collaborative-working relationship with clinical development leaders and staff within designated Affiliates to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
• Oversee quality and compliance in a regulated environment including AbbVie policies and procedures and country and regional standards and regulations.
• Lead and/or collaborate on development of risk identification and risk mitigation or control strategies for clinical research activities including clinical trials within designated countries with periodic reviews of quality and compliance data for the purposes of continuous improvement.
• Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy in designated countries and region in conjunction with other RDQA AREA personnel.
• Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent issues that impact clinical research. Drive vision of continuous state of regulatory preparedness.
• Ensure consistent understanding of the quality requirements for clinical research activities within Affiliates, works closely with Affiliates R&D Management on health of Quality System, identifies issues of quality and compliance that will impact overall goals and desired outcomes.
• Maintain awareness of all applicable regulations and develop appropriate standards to measure quality in assigned countries and region relating to clinical research.

Support Necessary Supplier Visits, Audits And Vendor Qualifications

• Develop inspection strategy in collaboration with AREA Associate Director and relevant functions and provide inspection-readiness support for all local / regional Health Authority inspections.
• Provide oversight, support and follow-up (inspection report response) for local Health Authority inspections with employees and management in assigned countries and region. Participate in Health Authority inspections as needed.
• Determine need for country/process assessments/audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits as required to assess compliance with regulations, guidelines, policies and procedures and Sponsor requirements. Effectively communicate audit results, both orally and in writing. Review and approve corrective action plans/audit responses.
• Support the development of robust audit and inspection responses through coaching and education.
• Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility.

Qualifications

• Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience.
• 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions that includes 3 years in in
• Strong understanding of local and global regulatory and legal requirements and of the approach and perspectives of regulatory agencies.
• Ability to ensure strategic risk focus with evolving global regulations and expectations. Agile and able to respond rapidly to unplanned events and changing regulatory requirements and expectations.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Motivates and can influence others, including those over whom they have no direct authority.
• Strong analytical skills with an ability to organize work in a logical, thorough & succinct manner.
• Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels.
• Excellent written & oral communication skills including presentation and influencing skills.
• Strong negotiation, influencing and collaborating abilities with excellent networking skills.
• Ability to foster cross functional collaboration teams.
• Strong team player or team lead and builds relationships with peers and cross-functionally at both global and local levels to drive performance.

Fluent In Additional Languages Desirable But Not Required.

Ability to travel as needed in AREA (up to 35%).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html