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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Pharmacovigilance QA (Audit) - New Role

Maidenhead, United Kingdom Req ID 2207734 Category Medical Division AbbVie

Job Overview

In this new role, you will be part of the PV leadership team and responsible for overseeing a team of Auditors, focused on delivering PV and quality excellence.  As an Associate Director, you will also schedule, plan and report PV and Regulatory Affairs audits, and act of a key point of contact to support business partners on technical, quality topics.  Overall, ensuring compliance with worldwide safety requirements and expectations.

Responsibilities:

  • Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and AbbVie policies and by continuous evaluation PV processes through audit and QA oversight activities.
  • Lead and contribute to the risk-based RDQA audit program, and work with audit stakeholders to resolve any non-compliance identified. Proactively identify opportunities to advance audit management and execution practices to improve the efficiency, effectiveness, and impact of the PVQA audit program.
  • Leads and 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.
  • Recruit, develop, manage, and mentor an international team of R&D Auditors. Build a strategic, high-performing team that operates cross functionally to build-in quality to AbbVie processes from the outset.
  • Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and people leadership. Effectively manage performance inclusively and equitably; provide timely and candid feedback throughout the year and appropriately reward and recognize valuable achievement.
  • Advances the AbbVie Quality System through leading development and implementation of systems and processes required to support global quality assurance requirements including audit, change and risk management, management review and continuous improvement processes.
  • Provides strategic input to the inspection support model and actively support PV inspections onsite or remotely to ensure PV inspections are a success. Support resolution of findings by working with R&D business partners.
  • Provides expert support and advice on PV regulations, guidance, and expectations to R&D QA and non-R&D QA stakeholders.
  • Encourages and supports a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement. Promotes continuous education for self and other AbbVie staff.
Qualifications:
  • Extensive experience in the biopharmaceutical industry or with a regulatory authority
  • Substantial experience in Quality Assurance auditing and pharmacovigilance
  • Demonstrated experience in people leadership
  • Advanced knowledge of global pharmacovigilance and auditing principles, including global and regional regulations and internationally recognized standards (e.g. ICH, FDA, EMA, ISO).
  • Experienced in the planning and execution of pharmacovigilance audits
  • Able to effectively communicate and influence across multiple stakeholders and manage within a cross-functional matrix; seen as a collaborative leader.
  • Ability to manage complex issues and distill information. Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.
  • Significant experience leading cross-functional and multi-location teams through complex projects with demonstrated flexibility to adapt to changing assignments and ability to effectively prioritize.
  • Demonstrates the willingness to make and accept unpopular decisions or take opposing positions.
  • Demonstrates ability to establish clear directions and operates with a strategic mindset. Utilizes creativity and original thinking
Travel: Yes, 15 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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