Senior Manager, Pharmacovigilance Quality Assurance Audit

Summary

Join AbbVie and become a key contributor to our Pharmacovigilance (PV) team. This role is primarily responsible for executing the PV audit program, ensuring compliance with global regulations and AbbVie policies. You will plan and conduct audits, resolve non-compliance issues, and contribute to the development and improvement of PV systems. Collaboration with business partners and other GxP RDQA functions is crucial. The position requires a strong understanding of quality systems, auditing standards, and PV regulatory requirements. This role offers the flexibility of remote work within the United States and a comprehensive benefits package.

Requirements

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• 5 years of experience in the biopharmaceutical industry or with a regulatory authority
• 5 years of experience in Quality Assurance and/or Pharmacovigilance
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above with a total of 10 years of experience
• Strong analytical skills and the ability to organize work in a logical, through and succinct manner
• Understanding of quality systems and auditing standards
• Knowledge of PV regulatory requirements and industry best practices
• Flexibility to adapt to changing assignments and ability to effectively prioritize
• Project management, interpersonal, and communication skills and ability to work independently and as part of a team
• Willingness and ability to perform international travel

Responsibilities

• Assure quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA oversight activities
• Contribute to the delivery of innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions
• Contribute to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies
• Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements
• Contribute to the PV audit program by planning and executing PV audits and working with auditees to resolve any non-compliance identified
• Actively participate in and support PV inspections onsite or remotely to ensure that PV inspections are a success and support resolution of findings by working with PV business partners
• Promote continuous education with regards to PV regulations and expectations for self and other AbbVie staff
• Participate in the analysis of PV compliance data and emerging regulatory intelligence to demonstrate appropriate QA supervision of the compliance of the AbbVie PV system

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• This role can be remote in the United States