Allergan Global Regulatory Quality Manager in Parsippany, New Jersey
Global Regulatory Quality Manager
Parsippany, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/901/other-jobs-matching/location-only
Oct 12, 2016Post Date
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 pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Manager, GRDQ, Quality Management Services is responsible and accountable for developing, implementing, and overseeing the GRDQ Corrective Action / Preventative Action (CAPA) Verification program.
The verification program includes audit and inspection CAPA surveillance and development and maintenance of a response and CAPA implementation tracking program for R&D. The scope includes internal audits and regulatory authority inspections of Allergan(AGN) and legacy entities and clinical investigators conducting studies on behalf of AGN for clinical trials, pre-clinical activities, pre- and post-marketing pharmacovigilance activities, and computerized systems that support these areas. The program also includes development of routine and ad hoc compliance metrics reporting on key performance indicators including timely CAPA implementation and effectiveness assessment.
This position collaborates closely with the GCP, GLP, GPV and CSV audit functions as well as Quality Management Services (QMS) to evaluate and utilize trends to identify and remediate gaps or other opportunities to reduce compliance risk for improvement.
This position provides onsite and remote inspection support as needed including, but not limited to, running the document room, maintaining the inspection management software program, scribing and request taking.
Responsibilities include, but are not limited to:
Design, implement and maintain a process for monitoring CAPA commitments
Conduct verification audits to assess timely completion and effective remediation based upon promised commitments
Provide guidance to the business on development of adequate and effective CAPAs for remediation of compliance risks to the company
Use TrackWise Tracking and Reporting tool for generating reports and metrics to assist in monitoring timely and adequate CAPA fulfillment of commitments
Communicate and escalate risks to the business
Develop and generate metrics monitoring timely and effective fulfillment of commitments
Support Regulatory Authority inspections and inspection readiness as assigned
Maintain up-to-date knowledge of FDA, ICH and other applicable regulations
This position requires up to 40% travel
Minimum of 10 plus years in quality assurance/compliance, auditing and/or operations experience required.
Strong working knowledge of regulatory requirements (e.g., regulations, guidelines, etc) for Good Clinical, Pre-clinical and Pharmacoviligance practices.
Proven knowledge and experience in CAPA management
Knowledge and experience with the Trackwise audit reporting tool is a plus.
Proven ability to provide a clear vision and ability to effectively implement that vision.
Strong written and verbal communication skills, demonstrated ability to function strategically and effectively at all levels.
Excellent negotiation and relationship building skills with proven ability to collaborate and influence key stakeholders and internal staff.
High degree of organizational awareness.
Good understanding of medical / corporate governance principles.
Demonstrated ability to develop sound solutions to complex problems.
Ability to ensure strategic risk focus and prioritize activities in response to the myriad of complex, inconsistent, and constantly evolving global regulations and expectations.
Minimum of a Bachelor’s degree in a scientific or health-related field with at least 5 plus
years of relevant industry experience.