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.
The Regulatory Compliance Manager is responsible for managing the regulatory compliance program, including but not limited to:
Manages LifeCell’s internal audit program and ensures internal audits are performed in accordance with internal procedures and relevant standards/regulations.
Coordinates and manages all external inspections performed of LifeCell by regulatory agencies and business partners and ensures responses from audit findings are submitted timely.
Leads field action evaluations and field action activities and completes 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).
Manages Quality assessments of major product/process changes or new markets. Identifies and prioritizes compliance risks at LifeCell and provides oversight to ensure appropriate actions are taken to remediate gaps or areas for improvement
Main Areas of Responsibilities
Manages LifeCell’s internal audit program. Ensures internal audits are performed in accordance with internal procedures and relevant standards/regulations, which includes but not limited to:
Propose annual internal audit schedule using a risk-based approach
Ensures all internal audits are executed per schedule and all required documentation, including but not limited to audit plan, audit report, GTW audit record etc. are completed timely per process requirements
Determines the need for focused audits based on compliance risk
Ensures auditors are qualified, independent, trained and assigned to each audit based on their qualification, competency and development needs.
Performs Compliance management approval of quality records
Performing the review and approval of internal audit reports
Ensures audit findings are assigned to the proper owners and all findings are resolved timely and effectively.
Escalates any major issues to upper management timely
Coordinates and manages all external inspections of LifeCell performed by regulatory agencies and business partners which includes but not limited to:
Manages inspection readiness activities including, but not limited to: scheduling audits, managing 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: ensuring adequate resources (host/backroom support, conference rooms, general logistics, equipment, personnel etc.) are available, any required mitigation actions are assigned /completed during the inspection, identifying and prioritizing compliance risks.
Ensures inspection responses and follow-up activities are completed as required including but not limited to: overseeing the progress of CAPAs generated from external audits and ensures the records are opened and advances timely per committed due date and escalating any potential issues or delays; drafting audit response based on the CAPAs and ensuring required reviews/approvals are performed and submiting response by due date, and CAPA actions are implemented and ECs are performed as required by due date.
Leads field action evaluations and field action activities and completes all necessary documentation as required. Responsible for draft/review all correspondences between LifeCell and regulatory agencies 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 completed as required.
Ensures CAPA is opened and the record advances timely as required
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.
Ensuring 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.
Excellent oral and technical writing skills with the ability to interface effectively cross-functionally and at all levels
Demonstrated leadership and organization skills
ASQ Auditor Certification or ISO lead auditor certification preferred
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