Senior Manager, Clinical Quality Assurance

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie seeks a Senior Manager of Clinical Quality Assurance to lead GCP quality activities across one or more clinical programs. You will develop the Comprehensive Quality Strategy, oversee audits, and ensure readiness for health authority submissions, driving proactive quality management in a matrix environment.

The role requires strong leadership, strategic planning, and deep knowledge of global regulatory expectations, with the ability to influence across Development Operations and partner

Qualifications

• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience.
• 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations.
• 1+ years of GCP QA auditing experience.
• Demonstrated leadership experience in motivating teams to anticipate and deliver strong operating results.
• Problem solving abilities required at both strategic and operational levels, ability to identify and resolve issues related to quality and compliance with global and local regulations.

Responsibilities

• Develop and manage timelines and deliverables for the RDQA Comprehensive Quality Strategy plan.
• Design and implement an audit program of internal and external compliance audits.
• Interpret and apply current governmental regulations to study protocols and activities.
• Prioritize activities to meet study and program objectives.
• Interact with Development Operations and supporting functions to ensure quality compliance across clinical development.
• Identify and mitigate clinical quality risks and escalate to management.

Skills

Leadership

Problem solving

Strategic planning

Cross-functional collaboration

Audit program management

Education

Bachelor’s degree in physical/life sciences or nursing/pharmacy

Job description

Senior Manager, Clinical Quality Assurance

• Full-time
• Salary Min: 124500
• Salary Max: 236500
• Workday Global Grade: 19
• Travel: Yes, 10% of the Time
• Compensation: USD 124,500 - USD 236,500 - yearly

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.

Purpose

Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, andensure compliance with corporate policies and functional procedures and applicable global regulations.

As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.

Responsibilities

• Develop andmanageproject timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management
• Assess the success and effectiveness of the quality system and assure inspection readinessby designing an audit program ofinternal and external compliance audits and applicable assessments
• Interpret,explainand apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities
• Prioritize activities to ensureobjectivesof studies/programs are met
• Interact withDevelopmentOperations organizationand supporting functions to ensure quality compliance across allaspects of clinical development;Identify and mitigatepotential clinical quality risks and escalateto management;Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities;Provide project/program leadership in quality as a team member across clinical development functions
• Anticipate, influence, anddeterminepresent and future business needs in support of quality for adrug developmentprogram
• Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
• Identifyand implement balanced fit-for-purpose quality management;Develop and recommend strategies and tactics for success
• Identifyand remove barriers that couldimpactprogramobjectives, priorities, timelines, and quality.Communicate risks and mitigations to management
• Serve as the primary program quality liaison during health authority inspections

Qualifications

• Bachelor’s degree in a physical science, life science, nursing,pharmacyor equivalentexperiencerequired
• 5+ years of pharmaceutical industry experience inGCPquality assurance or regulatory affairs or clinical development or clinical operations (oncology-specifica plus, but not a requirement). Prefer 1+ years of GCP QA auditing experience
• Successful and progressive leadership experience in motivating teams toanticipateand deliver strong operating results, as well as to meet or exceed customer expectations.
• Problem solving abilitiesrequiredat both strategic and operational levels, ability toidentifyand resolve issues related to quality and compliance with global and local regulations, polices, and procedures.This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.
• Demonstrated ability in strategic planningand cross functional execution
• Proventrack recordutilizing core and technical competencies in managing projectsin support of clinical research
• Strong understanding of global Pharma, clinical development and operations, legal and regulatory environments
• Experience in preparing/presenting key information
• Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner

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 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 employer 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.

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