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- Tasks: Lead audits to ensure compliance with global regulations and AbbVie policies.
- Company: AbbVie is a pioneering biopharmaceutical company focused on innovative health solutions.
- Benefits: Enjoy remote work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while working in a dynamic and supportive environment.
- Qualifications: Bachelor’s degree in science or healthcare; 5-7 years in Quality Assurance or Pharmacovigilance.
- Other info: This role offers flexibility and the chance to travel internationally.
The predicted salary is between 42000 - 60000 £ per year.
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Company Description
AbbVie\’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Company Description
AbbVie\’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose: Describe the primary goals, objectives or functions or outputs of this position.
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.
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.
This role can be remote within the US or the UK.
Qualifications
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 – 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
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Seniority level
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Seniority level
Executive
Employment type
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Employment type
Full-time
Job function
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Job function
Accounting/Auditing and Finance
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Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Senior Auditor, GVP Audit & Compliance employer: AbbVie
Contact Detail:
AbbVie Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Auditor, GVP Audit & Compliance
✨Tip Number 1
Familiarise yourself with AbbVie's mission and values. Understanding their focus on innovative medicines and compliance will help you align your responses during interviews, showcasing how your experience in pharmacovigilance and quality assurance fits into their goals.
✨Tip Number 2
Network with current or former AbbVie employees on platforms like LinkedIn. Engaging with them can provide insights into the company culture and expectations for the Senior Auditor role, which can be invaluable during your interview.
✨Tip Number 3
Prepare to discuss specific examples of your experience in leading audits and ensuring compliance with regulatory requirements. Highlighting your analytical skills and ability to manage risk-based methodologies will demonstrate your suitability for the role.
✨Tip Number 4
Stay updated on the latest trends and regulations in pharmacovigilance and quality assurance. Being knowledgeable about industry best practices will not only impress your interviewers but also show your commitment to continuous education in the field.
We think you need these skills to ace Senior Auditor, GVP Audit & Compliance
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Auditor position at AbbVie. Tailor your application to highlight relevant experience in Pharmacovigilance and Quality Assurance.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 5-7 years of experience in Quality Assurance and/or Pharmacovigilance. Provide specific examples of audits you've led or participated in, and how they contributed to compliance and quality improvements.
Showcase Analytical Skills: Given the analytical nature of the role, include instances where your strong analytical skills have led to successful outcomes. This could be through problem-solving during audits or developing risk-based methodologies.
Communicate Effectively: Since effective communication is key in this role, ensure your application reflects your ability to communicate audit results clearly. Use concise language and structure your documents logically to demonstrate your communication skills.
How to prepare for a job interview at AbbVie
✨Understand the Role Thoroughly
Before the interview, make sure to read the job description carefully. Familiarise yourself with the responsibilities and qualifications required for the Senior Auditor position at AbbVie. This will help you tailor your answers to demonstrate how your experience aligns with their needs.
✨Prepare for Technical Questions
Given the nature of the role, expect technical questions related to Pharmacovigilance and Quality Assurance. Brush up on relevant regulations and best practices in the industry. Being able to discuss these topics confidently will show your expertise and preparedness.
✨Showcase Your Leadership Skills
As this role involves leadership and oversight, be ready to share examples from your past experiences where you led a team or project. Highlight your ability to communicate effectively and manage risk-based decision-making processes.
✨Ask Insightful Questions
At the end of the interview, take the opportunity to ask thoughtful questions about AbbVie's audit processes or their approach to compliance. This not only shows your interest in the company but also gives you a chance to assess if it's the right fit for you.
