Associate Director, Pharmacovigilance Quality Assurance

AbbVie RDQA Pharmacovigilance Quality Assurance (PVQA) are champions for quality, ensuring complaint and risk based PV & RA solutions, whilst taking an independent pragmatic approach towards appraisal of PV systems to ensure the AbbVie PV systems are appropriate and effective to meet worldwide regulations and regulatory expectations. RDQA PVQA assures that AbbVie meets its global safety obligations through quality oversight and support of the Pharmacovigilance and Patient Safety Organization, affiliates, licensing partners, service providers and for pharmacovigilance activities within marketing activities and patient support programs.

Candidates can be remote.

Key Responsibilities Include:

• Assures quality and compliance in a regulated environment including AbbVie policies and procedures and country specific and other applicable standards and worldwide regulations by continuously evaluation PV processes.
• Delivers innovative quality strategies and solutions through collaboration with business partners and other GxP functions to support effective and timely solutions/responses to compliance issues/questions.
• Drives development / continuous improvement and implementation of necessary PV systems to assure compliance to worldwide regulations and corporate policies.
• Advances the AbbVie Quality System through leading development and implementation of systems and processes required to support global quality assurance requirement including audit, management review and continuous improvement processes.
• Leads PV audit planning, conduct, and resolution, including global audits.
• Actively participates in and supports PV inspections or remotely helps to make PV inspections a success and supports resolution of findings by working with PV business partners.
• Provides expert support on PV rules, regulations and guidance to QA and business colleagues.
• Promotes continuous education on PV regulations for self and other AbbVie staff.
• Generates, analyzes and reports PV compliance metrics to demonstrates key aspects of the PV compliance status.

• Bachelor's degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience.
• 7 years of experience in the biopharmaceutical industry or with a regulatory authority
• 5 years 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 experience.
• Strong analytical skills and the ability to organize work in a logical, through and succinct manner.
• Detailed knowledge quality systems and auditing standards
• Extensive 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.
• Extensive knowledge of PV processes for biopharmaceuticals.
• Willingness and ability to perform international travel

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Travel:
25% Travel