Director, Quality Assurance

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives.  As a quality organization in research & development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. 

AbbVie’s quality foundation resides in the Quality Policy and Quality System as an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. 

Working with and across the R&D GxP network ensuring sustained quality assurance compliance through the oversight, development, implementation, and maintenance of quality assurance systems and activities.  Generates new approaches to advance quality assurance compliance excellence mindset.  Serves as thought leader/expert in R&D Quality Assurance strategic process updates, proactively assesses evolving regulatory changes. Oversees generation and review of current/new GxP policies and directives to ensure that they meet and/or exceed GxP expectations.  

The incumbent of this role reports directly to the Head of R&D Quality Assurance and is a member of the R&D Quality Leadership Team.  There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.

Responsibilities:

·       Oversees the development/implementation of corporate and/or organizational GxP policies/procedures Provide quality assurance direction in various functional areas, groups and/or operations across R&D.

·       Works on abstract GxP issues across functional areas of the business.  Identifies and evaluates fundamental cross-functional quality issues through assessment of intangible variables.  Implement opportunities to advance benchmark performance.

·       Ensure timely, appropriate cross-functional quality assurance decisions/guidance across R&D where necessary and required. 

·       Serves as the expert quality assurance consultant regarding cross-GxP quality events requiring immediate action/robust remediation plans.  Lead cross-GxP investigations/CAPAs where required. 

·       In conjunction with the Compliance & Monitoring leaders across R&D, review all quality issue escalations across the GxP network to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure strategic continuous improvement and ongoing compliance.

·       Interacts internally and externally with other functional areas requiring negotiation of extremely difficult matters to influence GxP policy/procedural compliance and associated decision bodies both internally and externally.

·       Serves as the RDQA 1R&D Quality System Advisory Committee representative, and the final signatory on GxP quality assurance procedural level changes and associated GxP documentation.  Seek opportunities for simplification and efficiency across the GxP network and lead the codification of streamlined ways of working in network SOPs.

·       Prepares cross-GxP quality documentation as necessary and required for regulatory filings and/or reporting.  Assist in the review of written responses to regulatory inspectional observations and/or health authority reports, as required.

·       Serve as the primary R&D Quality Assurance representative thought leader in external industry forums and act as the responsible person in line with applicable directives & regulations for the preparation/communication with Health Authorities (e.g., recalls, defects, serious breach reporting).

·       Inspire transformative thinking and motivate employees to deliver transformative performance.

·       May lead a team (directly or indirectly) of professional staff and is expected to create an inclusive environment, focusing on growth and development, setting clear expectations, and engaging team members with clear vision on strategy and implementations. As a team leader, set clear goals that challenge team members to raise the bar on performance and enable adaptability and agility.

·       Lead and/or participate in the sharing of best practices and lessons learned to embrace evolving regulations/expectations

·       Bachelor's degree required, preferably in Life Sciences, Masters / Ph.D. is desirable but not essential. 

·       15 years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, quality systems, or a combination of those or comparable experiences.  Quality assurance, quality systems, quality compliance and/or audit background experience are highly desirable. 

·       Deep expertise and experience in interpretation and application of quality assurance/controls of regulatory requirements across multiple GxP areas and pharmaceutical/device platforms.

·       Well-developed leadership competencies including motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information.

·       10 years in the successful management of employees, including large groups where management of people managers and directors has been successful.

·       Excellent communication skills, including superior negotiation and influencing skills.  Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference.  Ability to manage difficult conversations and seek alignment.  Ability to motivate and develop high-performing teams with challenging goals that bring growth and development.

·       Strong, strategic, creative, and "big picture" thinker, considered a visionary. Proactive leader with well-developed management skills and the ability to anticipate and identify potential issues to address early to mitigate or prevent.  Demonstrated executive presence. Ability to make difficult decisions under pressure. 

·       Ability to direct and coach all aspects of work projects effectively within evolving and at times rapidly changing priorities and deadlines.

·       Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal and external stakeholders.

·       Evaluates performance, ability to differentiate various performance levels, and assists in career development planning for employees within responsibility.

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.

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