Purpose:

This role is responsible to assure that the AbbVie Research and Development (R&D) Quality System (QS) is compliant, continuously improving and aligned to AbbVie QS Policies, Procedures, and global regulations applicable across the various GxP areas in R&D. This is achieved through support and leadership of one or more of the core business activities within the team, incl. Quality Intelligence, Quality Planning, Management Review, Quality System Health & Metrics Program as well as supporting and leading QS Integration activities as applicable.

Responsibilities:

• Assure the AbbVie R&D Quality System is compliant, continuously improving and aligned with AbbVie Policies, Procedures, and global regulations across the various GxP areas in R&D
• Own and coordinate the R&D Quality Planning process incl. identification and inclusion of new Quality Plan items, initiation and support of associated Change Management plans, status monitoring of Quality Plan items, and presentation of overall Quality Plan status during R&D Management Review
• Support (and/or own) one or more of the following core GQS responsibilities and provide interpretation, guidance, and communication to functional areas in R&D related to: R&D Quality Intelligence & Surveillance, R&D Management Review, R&D Quality Health & Metrics, and R&D QS Integration activities; including related GxP regulations/guidelines, as well as internal QS policies/procedures
• Serve as primary GQS CI&I internal key contact for inquiries and activities related to internal audit, agency inspections, change management, CAPA, and risk-management related activities
• Collaborate with business partners in relation to core responsibilities to ensure efficient execution and compliance with regulations
• Influences and collaborates with R&D business partners at all levels, including management, to support effective and timely quality system continuous improvement activities incl. Quality Plan item completion
• Leads, facilitates, assists and/or supports Continuous Improvement and/or QS Integration projects (globally and cross-functionally as applicable) related to the R&D Quality Systems as needed and as assigned by GQS leadership
• Ensures compliance to Standard Operating Procedures by demonstrating accuracy and proficiency in daily critical/analytical thinking and decision making and escalates (potential) issues to management as required
• Drive continuous improvement by employing AbbVie leadership attributes and technical expertise and perform assigned core job responsibilities independently

Qualifications:

• Bachelor's degree in life Sciences, Pharmacy, Engineering, or related field required
• Minimum of 2-4 years’ experience in Pharmaceutical Industry (production and/or quality assurance) or related field
• Basic to advanced understanding and knowledge of GxP requirements and associated regulations
• Excellent oral and written communication and teamwork skills
• Proficient/Advanced knowledge in the Microsoft Office suite, specifically: Word, Excel, PowerPoint (be able to put together a moderately complex presentation
• Strong analytical, critical thinking skills as well as strong decision-making and issue resolution skills
• Strong leadership in time management, multi-tasking, and organizational skills
• Experience and knowledge of project management and/or lean six sigma methodologies, preferred
• Strong independent contributor and team member in a fast-paced, learning environment
• Experience working in a complex and matrixed environment desired

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.