Senior Manager, Clinical Quality Assurance

AbbVie; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a GCP Quality Lead in North Chicago to oversee quality activities across clinical programs. Key responsibilities include developing quality strategies, managing compliance audits, and leading cross-functional teams.

The ideal candidate should have a Bachelor’s degree and at least 5 years in GCP quality assurance or clinical development. Responsibilities include risk management, assuring inspection readiness, and articulating comprehensive quality strategies. AbbVie offers a competitive benefits package and is an equal opportunity employer.

Qualifications

• 5+ years in GCP quality assurance or clinical operations.
• Experience in leading teams to achieve operational results.
• Ability to solve strategic and operational quality issues.

Responsibilities

• Develop and manage project timelines for quality strategies.
• Design and execute an audit program for compliance.
• Communicate risks and implement quality management strategies.

Skills

GCP quality assurance

Regulatory affairs

Clinical development

Problem-solving

Leadership

Education

Bachelor’s degree in physical or life science, nursing, pharmacy

Job description

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 escalate 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.

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. This involves both internal cross‑functional problem solving as well as issue resolution between functional areas and 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.

Additional Information

• 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.

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.