Program Manager, Clinical Quality Assurance

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:

• Identify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigations to management
• 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;
• Prioritize activities to ensure objectives of studies/programs are met
• Identify and implement balanced fit-for-purpose quality management; Develop and recommend strategies and tactics for success
• Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
• Anticipate, influence, and determine present and future business needs in support of quality for a drug development program
• Provide project/program leadership in quality as a team member across clinical development functions
• 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
• Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities;
• Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management
• Serve as the primary program quality liaison during health authority inspections
• Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities

Education:

• Demonstrated ability in strategic planning and cross functional execution
• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations.
• 1+ years of GCP QA auditing experience
• Strong understanding of global Pharma, clinical development and operations, legal and regulatory environments
• 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations.
• Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner
• Experience in preparing/presenting key information
• Proven track record utilizing core and technical competencies in managing projects in support of clinical research
• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.