Senior Manager, RDQA (Americas)

BioSpace; North Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a Senior Manager, RDQA AREA, to drive quality excellence across discovery and development in the US. You will lead proactive quality initiatives, collaborate with affiliate R&D teams, and ensure regulatory readiness for clinical research activities.

Focus is on implementing the One AbbVie Quality System, CAPA, Change Management, and Quality Risk Management while guiding the region toward first-pass approvals and robust data integrity.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy, or other medical science with equivalent experience.
• 8+ years of biopharmaceutical/medical device qa, compliance, regulatory affairs, clinical research, including leadership roles.
• Strong understanding of local and global regulatory requirements and agency expectations.
• Ability to travel up to 35%.

Responsibilities

• Provide governance and oversight for RDQA activities in designated countries/regions.
• Lead and/or collaborate on risk identification and mitigation strategies for clinical research.
• Develop and drive RDQA quality measures and the quality strategy to achieve first-pass approvals.
• Coordinate and support inspections, audits, and corrective action plans.
• Foster cross-functional collaboration with Affiliates, R&D management, and external partners.

Skills

Quality assurance

Regulatory compliance

Clinical research

Auditing

Leadership

Regulatory affairs

Education

Bachelor's degree in Biology/Pharmacy or related

8+ years biopharma/medical device experience

Job 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

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 life 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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. AbbVies 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
• within designated Affiliates in the assigned countries and region.
• 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 inin leadership positions (people and/or initiatives/projects).
• 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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