Associate Director, Pharmacovigilance QA (QMS) – New Role

• Could be UK or US/ home or office based

Job Overview

Acting as part of the PV leadership team, this new position will be overseeing a team of quality professionals, focused on delivering PV and Regulatory Affairs quality excellence.  As an Associate Director, you will be overall responsible for the promotion and implementation of R&D quality standards.  Identify opportunities and implement proactive quality measures to supplement, enhance and inform the routine PVQA audit program and to support PV system compliance.

Provide of advice and support on technical and quality topics to business partners to ensure 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.
• Provides leadership and strategic insight to the Abbvie Quality System to drive enhancement and advancement of the AbbVie PV and RA Quality System. Develop and implement proactive quality assurance models and methods to ensure optimal QA oversight and partnership with business stakeholders to drive continuous improvement.
• 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 quality professionals. 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.
• 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.
• Generates, analyzes and reports PVQA metrics to demonstrate compliance status, Elevate the use of routine metrics and other compliance data to drive process improvement and efficiency.

• Extensive experience in the biopharmaceutical industry or with a regulatory authority
• Substantial experience in Quality Assurance and pharmacovigilance.
• Demonstrated experience in people leadership
• Advanced knowledge of global pharmacovigilance and quality principles, including global and regional regulations and internationally recognized standards (e.g. ICH, FDA, EMA, ISO).
• Experienced in leading the development of quality documents such as SOPs, deviations and associated CAPA, audit reports, change management and quality risk management records.
• 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