Senior Manager, Clinical Quality Assurance

Regulatory Toolkit; Chicago (IL); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

PTO

Job summary

AbbVie is seeking a Senior RDQA professional to lead GCP quality activities across one or more clinical programs. You will shape the Comprehensive Quality Strategy, coordinate internal and external audits, and ensure readiness for health authority submissions.

Work cross-functionally with Development Operations and other RDQA functions to mitigate quality risks and maintain program oversight. Location options include North Chicago, Irvine, South San Francisco, Worcester, Dublin, or Maidenhead.

Qualifications

• Bachelor’s degree in a physical or life science, nursing, pharmacy or equivalent experience required.
• 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development or clinical operations.
• Leadership experience motivating teams to deliver strong operating results and meet expectations.
• Ability to identify and resolve quality/compliance issues with global and local regulations.
• Strategic planning and cross-functional execution capabilities.

Responsibilities

• Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan.
• Design and implement an audit program with internal/external audits and assessments.
• Interpret and apply current governmental regulations, guidelines, policies, and procedures to study protocols.
• Interact with Development Operations to ensure quality compliance across clinical development functions.
• Lead the integrated cross-functional and comprehensive quality strategy plan.

Skills

GCP QA

Regulatory affairs

Clinical development

Cross-functional leadership

Problem solving

Education

Bachelor’s degree in physical or life science

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, visit www.abbvie.com.

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, and ensure 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 and manage project 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 readiness by designing an audit program of internal and external compliance audits and applicable assessments
• Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities
• Prioritize activities to ensure objectives of studies/programs are met
• Interact with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development; identify and mitigate potential clinical quality risks and elevate to 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, and determine present and future business needs in support of quality for a drug development program
• Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
• Identify and implement balanced fit-for-purpose quality management; develop and recommend strategies and tactics for success
• Identify and remove barriers that could impact program objectives, priorities, timelines, and quality; communicate risks and mitigations to management
• Serve as the primary program quality liaison during health authority inspections

This role can be located in North Chicago, IL, Irvine, CA, South San Francisco, CA, Worcester, MA, Dublin, Ireland or Maidenhead, UK.

Qualifications

• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required
• 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations (oncology-specific a plus, but not a requirement). Prefer 1+ years of GCP QA auditing experience
• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations
• 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, policies, and procedures, including internal cross-functional problem solving and issue resolution with external collaborators
• Demonstrated ability in strategic planning and cross functional execution
• Proven track record utilizing core and technical competencies in managing projects in 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

Compensation & Benefits

• The compensation range is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation will depend on many factors including geographic location, and may be more or less than the posted range.
• 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 remains in the Company's sole and absolute discretion unless and until paid, 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: https://www.abbvie.com/join-us/reasonable-accommodations.html