Quality Systems Associate Director

Responsible for and manages the full AbbVie global supplier/TPM audit schedule including supporting procedures systems and planning. Additionally manages provides strategy and support to audit planning team

This includes being business system owner of onetrack for supplier/audit (as well as Soltraqs and GTW) IT system and ensuring the accuracy (records) and execution (function) of system vs process. This role owns the external audit process and procedures (including changes process improvements and updates to procedures process and systems) and leads the external audit Community of Practice (COP) quarterly updates to ensure alignment of process and potential improvement across the users.

Owner and team is responsible for process execution for managing system changes for 300-500 supplier changes (supplier additions removals and record or system changes) annually.

Additionally this leader and team is responsible for reporting on all external auditing metrics and performance as well as ownership for all Change Plans (CPs) exception events (ERs/NCRs) and Project Management/tracking of projects within the external auditing team.

Finally this leader is the primary contact for all audit and inspection support for agency internal and notified body audits related to external audits and audit process.   

Responsibilities

• BPO system oversight and management for Onetrack auditing and supplier management module
  • Define SQM/supplier audit user requirements and drive system change/enhancements to ensure the system aligns with current business process from beginning to end. Collaborate with BTS to manage incident reporting and define appropriate corrective actions. Develop training materials and continuity planning.
  • This includes ensuring accuracy and maintenance of approximately 3800 quality relevant suppliers in the supplier auditing scope.
• Oversight of annual global external audit schedule ( 400 OSA 200 global QQ and 600 local QQ; approx. 800 changes a year with supplier removals additions and updates) supporting approximately 3800 quality relevant suppliers/TPMs across Abbvie
  • Managing schedule updates to plans and annual and global planning of external audit schedule. Opening and closing of scheduling including local low QQs
  • Ensuring audit prep and audit support for all audits.
  • Team vets and manages all proposed changes and confirms expectations vs process and  support of the changes (CP)
• Team owns QMRand supporting work instructions and tools for process and any changes.
  • Responsible to identify and support process and procedure improvement within audit and supplier management scope (help identify and eliminate pain-points through process improvement and procedure enhancements)
• Team owns quarterly auditing CoP and key contributor for Supplier CoE
• Team is responsible for all CPs ERs and Projects executed within audit team.
• Team is responsible for tracking training coordination needs within external auditing team
• SME and support for all audit and inspection requests for agency notified body and customer audits for Abbvie for auditing
• Team is responsible for monthly reporting of all metrics
  • Includes tracking new suppliers added removed and discontinued suppliers cleansed from auditQ and process execution (including CPs ERs and projects)

Qualifications :

• Bachelors degree in relevant life science engineering or other technical discipline (or equivalent work experience to ensure understanding of implications of role to organization and industry) required.
• Total combined years of experience 10 years in the pharmaceutical biologics device or chemical industrya minimum of 5 years of experience in QA operations and 4 years of experience in supplier quality management or similar experiential role.
• Expert knowledge and a comprehensive understanding of supplier quality management requirements and expectations (focusing on Abbvie and industry expectations). Working knowledge and experience to support agency and notified body inspections queries requests or potential deficiency concerns.
• Strong leadership skills are required to manage professional staff and effectively interface with senior leaders within the organization (especially with managing project requests and challenges with highly visible or challenged projects or project timelines). Capacity to perform as a leader team member and individual contributor as needed.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency positive interpersonal skills and the ability to manage multiple complex tasks simultaneously.
• Understanding strategy and tactical needs for auditing organization; to analyze data and facts to support process changes and improvements to meet the expanding needs of supplier auditing within Abbvie.
• The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate Divisional regional and local objectives to effectively manage the action plans.

Key Stakeholders:

Abbvie manufacturing site teams (site supplier quality assurance procurement and supply chain) Affiliate QA teams external manufacturing support teams (E&PQA external contract manufacturing procurement and supplier controls) Business Technology Services (as BPO for onetrack scope) R&D (process and shared audits) and QA leadership (supporting sites teams and reporting).

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 postingbased 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 paymore 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. 

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 commissionincentive 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 untilpaid 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