Director, Quality Systems

Purpose Statement 

This role serves to provide leadership in the Quality Operations function to support and drive strategic initiatives continuous improvement and management of the Quality Center of Excellence in cooperation with the Center of Excellence leads. This position holder will hold responsibility for working closely with regulatory intelligence team and improve AbbVie Global Quality System by ensuring external and internal regulatory and business signals are translated into improvements of the different Quality System elements to consistently deliver compliance and high-quality product. These signals include new or changed external regulations observations from AbbVies regulatory inspections and competitors enforcement actions AbbVies strategic objectives and continuous improvement needs.  The responsibilities qualifications and experience required for this position are presented below.

Major Responsibilities:

• Provide directions leadership and guidance to the Center of Excellence Leads (CoE) in a matrix organization (currently 18 global CoE Leads mostly on a Director- or Associate Director level across 20 Centers of Excellence)
• Manage the Quality System and Centers of Excellence to ensure alignment with regulatory standards and guidance. Drive a continuous improvement philosophy to ensure the CoEs are being managed to deliver a quality system that consistently meets regulatory requirements. Drive alignment of CoE activities with the Global Operations Quality strategy.
• Own drive and continuously improve the process to identify relevant enforcement actions of key regulatory agencies including FDA EMA MHRA HPRA for AbbVies collaboration with global CoE leads assess the potential impact on AbbVies quality system and identify appropriate actions.
• Work with relevant cross-functional teams to investigate operational/process inefficiencies for the identified initiatives and working with the business to design improvements and implement efficient/effective systems. Project Manage Quality Operations process improvement initiatives to address the identified inefficiencies in partnership with the process owner and relevant stakeholders.
• Ensure that findings during inspections at one site or affiliate are assessed for potential impact on the global network (all other manufacturing sites or affiliates). Work with the CoEs to close identified gaps.
• Lead and coordinate activities in support of mergers acquisitions and divestitures through the integration of the quality system
• Provide mentorship leadership and prioritization to team members to execute their respective duties.
• Lead coordinate and engage the CoE Team and manage CoE-related resources like SharePoint SME-lists annual plans; conduct Community of Practice (CoP) meetings

Qualifications :

Qualifications

• Position requires BS degree in a science related area.
• 10 years of Quality Regulatory and/or Operations experience with significant situational leadership experience.
• This role requires strong organizational skills strategic thinking project management leadership skills and strong understanding of the pharmaceutical business.
• The incumbent must also have a solid understanding of the quality and regulatory requirements of the medical device regulations.
• Requires an in-depth understanding of the pharmaceutical product development cycle.
• The position requires human relations and administrative skills necessary to establish and maintain effective working relationships with team members co-leaders and senior management in quality manufacturing supply chain finance information systems and engineering.
• The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed.
• Excellent presentation and interpersonal skills required.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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. 

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Work :

No

Employment Type :

Full-time