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Quality Systems Business Specialist

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Quality
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188474 Requisition #
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Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
 
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients.  Power your future & join our bold team.
 
Position Overview
 
Under the direction of the Executive Director, Quality, the Quality System Specialist is responsible for providing leadership to create and maintain a metrics-driven OPEX culture in the quality organization. Applies knowledge of quality systems and expertise to analyze and solve problems to improve the site quality team’s results. Provides input on resource planning and policy development. Specific responsibilities of this position impact the effectiveness, compliance, and efficient results of the organization by:  1) ensuring overall compliance to regulations for metrics reporting 2) creating a metrics system that drives us to “do the right thing” 3) understanding of overall business to always provide safe and compliant products to our customers/patients and 4) driving a strong metrics and OPEX focused culture for the quality organization and Branchburg site.
 
Main Areas of Responsibilities
  • Manage the key metrics for Branchburg’s Quality organization. Support existing metrics reporting requirements including but not limited to: Quality Health (monthly), Site Business Review (monthly), Quality Systems Management Review (quarterly), and Post Market Surveillance Review (bi-annually). Ensure metrics are reported accurately and consistently and meetings happen on time and are carried out according to defined processes and procedures.
  • Drive corrective actions to improve metrics. Ensure key metrics are integrated into Tier and monthly review processes. Work with quality leaders to make critical metrics visible and owners accountable. If metrics turn “red” ensure right level of action is being taken (and prioritized) to address root causes and improve our systems. Lead cross functional efforts as needed. Facilitate root cause problem solving sessions, lessons learned, OPEX and DMAIC tools as appropriate to put metrics on path to green.
  • Be a resource to quality leadership team. Partner with site leadership on an ongoing basis to help prioritize projects to improve our site performance. Lead projects as required to improve quality culture, metrics, process, etc. Lead efforts as directed by site quality leadership team.
  • Develop and lead the quality “community” of metrics data analysts to create metrics driven culture. Partner with key departmental metric owners to understand sources of data, key fields, limitations, and opportunities to leverage data across the organization. Work with owners to build standard work and be able to back up departmental analysts. Lead community to create monthly calendar for all metrics, build a centralized repository for all metrics/standard work, develop and enhance knowledge and skills across the community, integrate metrics into tier structure to drive appropriate actions, and share best practices across the site and the Allergan organization. Create formal and informal communication channels. Be a resource to assist all metric owners to make their processes are effective and efficient.
  • Monitor and implement processes to insure compliance with regulations and guidelines, including but not limited to FDA 21CFR 1271 and 820, ISO 9001 and 13485, Canadian regulations, AATB and state regulations. Leverage best practices in the industry and with key corporate and med device site partners. Own and maintain the procedures for Post Market Surveillance, Quality Management System Review, and other procedures as assigned.

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Requirements:
  • 3 - 5 years of experience within Medical Device, Pharmaceutical, Human Tissue, or other regulated industry.
  • 3-5 years of experience in a quality analyst, operations analyst, or other quality related responsibility.
  • Demonstrated knowledge in Quality Systems
  • Quality operation practices and procedures
  • Ability to work on cross functional teams and apply influencing skills in a matrix environment along with the ability to partner with and influence key internal and external stakeholders. 
  • Excellent oral and written skills, with the ability to interface effectively and professionally at all levels. 
  • Above average experience with Excel/PowerPoint data analysis and reporting
  • Incumbent should be comfortable with complex spreadsheets including pivot tables, lookup functions, conditional formatting, and other complex spreadsheet functions.

Preferred Skills/Qualification

  • Lean, Six Sigma training and expertise preferred
  • ISO training and/or certification preferred

 

Education

  •  Bachelor's degree in Science, Business, Engineering, or related discipline, or equivalent work experience is required.

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Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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