AbbVie Associate Director, Safety Compliance in Lake County, Illinois
Associate Director, Safety Compliance
USA, Illinois, Lake County
Research & Development
This newly established position reports into the Safety Compliance function of thePharmacovigilance and Patient Safety (PPS) organization. Safety Compliance is a high-profile, high-impact team, enabling pharmacovigilance excellence through the establishment, maintenance, execution and oversight of the AbbVie Pharmacovigilance Quality System, and acting as a Centre of Excellence on pharmacovigilance quality standards. The team plays a critical role in advising and engaging various internal stakeholders on pharmacovigilance requirements and mechanisms to maintain at minimum regulatory compliance and furthermore promoting excellence.
With practical experience of pharmacovigilance quality systems, audits and inspections, the Associate Director Safety Compliance will take a leading role in the development and implementation of the PPS strategy for pharmacovigilance audits and inspections, partnering closely with stakeholders within PPS and the broader R&D organization. The role will drive the holistic approach to the investigation, analysis and impact assessment of compliance, quality and regulatory intelligence, and the development of associated robust action plans. The scope extends to pharmacovigilance activities worldwide and spans the life cycle of all products.
Collaborates with Pharmacovigilance (PV) leadership, PV QA, Operations QA and Device Center to ensure a consistent understanding and application of quality management principles
Assesses current processes and practices against relevant PV, Device and Combination product regulatory guidance and AbbVie policies. Leads a variety of QS internal and external activities related to PV,
Analysis and investigations of system failures and risks, including correction and corrective/preventative actions and evaluating the involved risks.
Monitors compliance, metrics and trending of worldwide adverse event regulations and guidelines.
Ensures the Global PV system is compliance with Global Pharmacovigilance Regulations
Conceives, leads and contributes to major process improvement system enhancements, or other projects impacting the PV Quality System
Participates in audits/inspections and CAPA investigations/corrections.
Creates flexible and resilient processes where organizational and business changes are managed effectively; delegates effectively but with oversight to empower; leverage, and develop staff; establishes a climate to ensure that effective decisions are made in a timely manner
Establishes clear communication channels within the department and across functional teams for both internal and external clients
Bachelor’s Degree in Science, Health Related, or Quality field, Advanced Degree preferred. 2-5 years industry experience or equivalent.
Minimally 2 years Quality System Management and 3-5 years management experience/experience leading teams and/or managing staff.
Working knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced