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Associate Regulatory Compliance Analyst

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Quality
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189414 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 supervision of Regulatory Compliance management, the Regulatory Compliance Auditor/Analyst will support all aspects of the Regulatory Compliance processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified.
  • Supports LifeCell’s internal audit program and performs internal audits under the guidance of lead auditor in accordance with internal procedures and relevant standards/regulations.
  • Coordinates external inspections performed of LifeCell by regulatory agencies and business partners and supports the completion of audit responses as needed.
  • Supports field action evaluations and field action activities and compiles/archives all necessary documentation and correspondences between LifeCell and regulatory agencies as required.
  • Manages the assessment process for new or revised external standards/regulations for applicability and impacts to LifeCell’s Quality Management System (QMS).
  • Supports Quality assessments of major product/process changes or new markets. Identifies and communicates compliance risks at LifeCell to ensure appropriate actions are taken to remediate gaps or areas for improvement. Completes customer surveys as needed.
     

Main Areas of Responsibilities

 

Supports LifeCell’s internal audit program and performs assigned internal audits under the guidance of lead auditor in accordance with internal procedures and relevant standards/regulations, which includes but not limited to:

  • Ensures all assigned internal audits are executed and all required documentation is submitted to lead auditor, including but not limited to audit report, GTW audit record etc. are completed timely per process requirements or as assigned by lead auditor
  • Proposes the need for focused audits based on compliance risk
  • Works with cross functional areas on audit CAPAs and ensures their timely completion. Manages the reviews and approval of audit records and the associated CAPAs.
    Escalates any major issues to management timely.
     

Coordinates external inspections performed of LifeCell by regulatory agencies and business partners and supports the completion of audit responses as needed, which includes but not limited to:

  • Supports inspection readiness activities including, but not limited to: scheduling audits, supports audit readiness activities, creating training material and conducting organizational awareness and audit readiness trainings, identifying subject matter experts (SMEs) and host/backroom support, and coordinating audit logistics. 
  • Coordinates external inspections including, but not limited to: Acts as backroom lead or support, coordinates conference rooms, general logistics, equipment, personnel etc., supports any mitigation actions identified during the inspection, identifies and communicates compliance risks.
  • Provides required support to inspection responses and follow-up activities including but not limited to: oversees the progress of CAPAs generated from external audits and ensures the records are opened and advances timely per committed due date and escalates any potential issues or delays; drafts audit response based on the CAPAs and ensures required reviews/approvals are performed, and CAPA actions are implemented and ECs are performed as required by due date.

 

Supports field action evaluations and field action activities and compiles/archives all necessary documentation and correspondences between LifeCell and regulatory agencies as required, which includes but not limited to:

  • Drafts field action evaluation form and coordinates field action evaluation committee meetings as needed.
  • Coordinates with Allergan Recall Coordinator for the execution of all field actions and ensures all field actions are executed per relevant regulations and LifeCell internal process requirements and all required paperwork is in place.
  • Ensures notification and all correspondence with International, Federal and State agencies, Tissue Recovery Partners and Distribution Partners are received and archived as required.
  • Ensures CAPA is opened and the record advances timely as required.
  • Supports product reconciliation and destruction and ensures all required paperwork is received and archived

 

Manages the assessment process for new or revised external standards/regulations for applicability and impacts to LifeCell’s Quality Management System (QMS) which including but not limited to:

  • Ensures all applicable regulations and standards are identified and included in LifeCell’s applicable regulations/standards list.
  • Ensures the assessment of new/revised standards/regulations for changes impacting LifeCell are identified and necessary changes are implemented timely.
  • Ensures completion of gap activities identified on LCF05.01.023.02 External Standards/Regulations Gap Assessment and closure of LCF05.01.023.01 Assessment Request of External Standards/Regulations by tracking ECR to closure, when applicable.
  • Manages review/approval of LCF05.01.023.01 Assessment Request of External Standards/Regulations at completion of assessment.
  • Ensures new/revised regulations/standards are uploaded into Doc Management system.
  • Performs assessment related to Regulatory Compliance processes

 

Supports Quality assessments of major product/process changes or new markets. Identifies and communicates compliance risks at LifeCell to Regulatory Compliance management to ensure appropriate actions are taken to remediate gaps or areas for improvement. Completes customer surveys as needed. Responsibilities include but not limited to:

  • Completes assigned quality assessments for major product/process changes or new markets timely.
  • Identifies and communicates internal risks and ensures quality issues are tracked/addressed timely.
  • Completes QSMR metrics associated with the area of responsibility.
  • Works collaboratively with other departments to address quality/compliance gaps or implement process improvement.
  • Completes customer surveys as needed.
The following listed requirements need to be met at a minimum level to be considered for the job:
  • Knowledge of applicable FDA and international standards/regulations including ISO13485, 21CFR820, applicable EU medical device and animal tissue directives/associated standards, Canadian regulations for human tissue and/or medical devices and Australian TGA medical device regulations etc. 
  • Analytical skills and ability to apply statistics and metrics to process improvement models.
  • Ability to work on cross functional teams and apply influencing skills in a matrix environment.
  • Ability to aseptically gown and work in a controlled processing environment working with human and animal tissues.
  • Ability to travel up to 15%.

  

Preferred Skills/Qualifications

 

The below skills are attributes that may not be mandatory but are definitely desired in the ideal candidate.

  • Experience with Class II and/or Class III medical device.
  • ASQ Auditor Certification or ISO lead auditor certification.
  • Excellent oral and technical writing skills with the ability to interface effectively cross-functionally and at all levels.
  • Demonstrated leadership skills.

 

Education

  • A Bachelor’s Degree

 

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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