Program Manager, Clinical Quality Assurance

Summary

Join AbbVie as a Program Manager - Clinical Quality Assurance and lead the management of GCP quality activities across clinical programs. You will drive proactive quality management, ensuring compliance with regulations and corporate policies. As the primary GCP quality interface, you will influence cross-functional activities, contributing to submission-ready quality data and market authorizations. This independent contributor role requires strong leadership and problem-solving skills within a matrix organization. You will develop and manage project timelines, assess quality systems, interpret regulations, and mitigate risks. The position offers the flexibility of remote work within the US.

Requirements

• 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
• 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, 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 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

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

Preferred Qualifications

1+ years of GCP QA auditing experience

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• This role can be remote in the US