Senior Auditor

AbbVie
Summary
Join AbbVie's Pharmacovigilance (PV) team as a key contributor to the execution of the PV audit program. You will be responsible for scheduling, planning, reporting, and resolving PV audits, ensuring alignment with RDQA policies and procedures. Lead and oversee risk-based decision-making for the audit program, providing advice and support on PV and quality topics to business partners. This role involves leading PV audits, assimilating audit observations, and reviewing corrective action plans. You will also contribute to the development and implementation of systems and processes to support global quality assurance requirements. This remote position (US or UK) offers opportunities for professional growth and development within a leading biopharmaceutical company.
Requirements
- Bachelorβs 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 β 7 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
- Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA consultation activities
- Lead PV audits (internal system and/or process, affiliates and third parties) to ensure compliance to global regulatory and AbbVie requirements. Effectively communicate audit results, both orally and in writing
- Assimilates audit observations and compilation of PV audit reports and reviews and approves Corrective Action Plans submitted in response to audit observations within target timeframes. Track actions through to completion
- Assist in the design, planning and execution of risk-based methodologies to inform the annual PVQA audit plan
- Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements
- Contributes to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies
- Provide critical audit related data, updates and scheduling content to assure accurate maintenance and reporting of the Product Safety Master File (PSMF) globally
- Leadership of PV Internal Audit SME role supporting PV inspections and License Partner audits of AbbVie onsite or remotely to ensure that PV inspections are a success
- Promotes continuous education with regards to PV regulations for self and other AbbVie staff. Support team members in their development and training
Benefits
This role can be remote within the US or the UK
Share this job:
Similar Remote Jobs
