Allergan *Director, Recalls & Agency Alerts in Madison, New Jersey

*Director, Recalls & Agency Alerts

Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5826/other-jobs-matching/location-only

Jun 28, 2018Post Date

180698Requisition #

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

The scope of this role includes global oversight of product recalls, leads the Recall Committee, ensure compliant management of US recalls, program management of the Rapid Alert process, supporting investigations associated with potential counterfeit/tampering cases, ensuring all regulatory Agency correspondence regarding potential product quality issues and potential or actual market action is timely and complies with established corporate standards, and monitoring the Sales Operations activities associated with Pharmaceutical Drug Marketing Act. This role is also responsible for monitoring for market action related trends internally and associate industry trends externally. The role oversees all commercial products for the Allergan organization at a global level. This role is at a corporate level and has a global span.

Supervisory responsibility:

This role includes the authority to hire, promote, and manage performance of up to 5 direct employees with responsibilities focusing on the Post marketing Quality elements provided above.

KEY DUTIES AND RESPONSIBILITIES:

Maintaining global, robust Post Market Quality processes related to recalls, market withdrawals, and US Agency notifications for all product types globally. Demonstrate excellence and expertise in communications with the FDA and all other applicable regulatory authorities, as needed. These critical systems/programs are essential to patient safety and brand protection and must be adequately defined and maintained in the Allergan Quality Management System.

Global Program Ownership and Harmonization – Ensure alignment of recall processes, market withdrawals, Rapid Alerts, and Agency notifications are processed per local Agency requirements and monitor progress of critical issues to closure. Escalate any critical issues and ensure each are driven to resolution. Also, monitor for consistency in how these are managed, particularly those that affect more than one site and more than one market.

Ensure consistent reporting and follow up on Field Alerts, Biological Product Deviation Reports, DSCSA, (relevant to the US market), PDMA reporting, and other regulatory notifications. Monitors and reports to leadership any critical issues to ensure on-time and adequate resolution.

Directs required actions for all recalls globally and serve as the leader of the Recall Committee, including providing recommendations for recall classifications and levels. Lead team who manages recalls of Allergan products from the US market. Coordinate with TPQC on management of international recalls.

Works with all sites and Third Party Quality to ensures consistent reporting of and follows-up on Rapid Alerts.

Oversee applicable Post Market relevant metrics and analyses of trends.

Requirements

  • BA/BS in scientific discipline required.

  • MS or PhD related to the industry preferred

  • Minimum of 8 - 12 years of experience in pharmaceutical and/or medical device industry.

  • Extensive experience with recall administration preferred.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

  • Demonstrated knowledge of global regulatory requirements ensuring compliant business processes for global recalls/market withdrawals, Field Alerts/Quality Defect reporting, PDMA reporting, Counterfeit/Tampering reporting, and 5 day MDR reporting.

  • Exceptional written and verbal communication is required for this role, as s/he will serve as the lead contact for critical Agency communications externally. Additionally, this role will serve as the primary internal point of contact for all market action and recall related issues/questions. Internally, this includes engagement with Commercial teams, Legal counsel, Corporate Communication, Global Safety, Regulatory Affairs, all sites, TPQ, and any other impacted groups. As such, clear and effective communication is essential to this role.

  • Excellent teamwork is required to support our sites and TPQ teams as they work to resolve complex product and production related issues oftentimes during periods of high urgency and high safety/compliance risk. This person must maintain a positive, constructive approach while driving alignment between business needs and Agency expectations.

  • Strong awareness of the impacted business model for each product type necessary to effectively and quickly implement actions relevant to all commercial product types.

  • Strong attention to detail is required to ensure effective analyses and decision making relevant to marketed products in different geographical regions is complex and requires a high level of integrity, commitment and proactiveness. Must be willing to think creatively and willing to work along with sites and Third Party Quality to execute the decisions made by the Recall Committee and leadership.

  • This is a key role for setting strategies relevant to recalls impacting post market quality. This role is at a corporate level and has a global span.

  • This role requires excellent problem solving and influencing skills both in relation to communications with cross-functional internal colleagues, as well as in communications with Regulatory Authorities.

  • The role will have up to 5 direct reports. This involves hiring, promotions, terminations, and performance management.

Education

  • BA/BS in scientific discipline required.

  • MS or PhD related to the industry preferred

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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.