Program Manager – Clinical Quality Assurance Full Time

Summary:

• 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.
• The company strives to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in its Allergan Aesthetics portfolio.
• For more information, visit www.abbvie.com.
• Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

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.
• 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 efforts 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.

Requirements:

• 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, regulatory affairs, clinical development, or clinical operations.
• Prefer 1+ years of GCP QA auditing experience.
• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results and meet or exceed customer expectations.
• Problem-solving abilities at both strategic and operational levels to identify and resolve issues related to quality and compliance with global and local regulations, policies, and procedures.
• 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, operations, legal, and regulatory environments.
• Experience in preparing/presenting key information.
• Comprehensive knowledge of the interrelationship among other RDQA GXP functions and business functions to serve as a good business partner.

Benefits:

• Comprehensive package including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance, and 401(k) for eligible employees.
• Short-term and long-term incentive programs.
• Note: The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation are at the company’s sole discretion.