Clinical Quality Assurance Manager

4 weeks ago

Irvine, California, United States AbbVie Full time
Job Summary

We are seeking a highly skilled Clinical Quality Assurance Manager to lead the management of GCP quality activities in support of studies and projects across one or more clinical programs. The successful candidate will drive proactive quality management, ensure compliance with corporate policies and functional procedures, and applicable global regulations.

Key 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
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 or regulatory affairs or clinical development or clinical operations
  • Prefer 1+ years of GCP QA auditing experience
What We Offer

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 short-term incentive programs and 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 employee 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.

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