Allergan Executive Director, Quality Assurance in Waco, Texas
Executive Director, Quality Assurance
Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/5615/other-jobs-matching/location-only
Jun 06, 2018Post 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 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.
Plans, organizes, directs, and provides strategic direction for Allergan Waco’s quality assurance and quality control functions. Ensures compliance to all criteria established by the U.S Food and Drug Administration, ISO and other EAME Ministries of Health are met using efficient systems and processes. Manages all interactions with external regulatory agencies, as well as coordinating the interface with internal corporate departments as required. Works with the VP Quality OperationsSpecialty Manufacturingand the VP Operations to set strategic direction for the quality strategy and culture at the Waco facility.
This position has full responsibility and accountability to act and make decisions in the respective job duties. This position has a solid line reporting relationship to VP, Quality Operations Specialty Manufacturing and a dotted line to the VP Operations. This role is part of the Senior Management team for the Allergan Waco Manufacturing facility which oversees the general management of the site and the long term Master Planning for the facility.
The Executive Director works with the FDA and other regulatory bodies to proactively ensure that new processes are implemented with the understanding and guidance of the regulatory bodies. When required, this position will support supplier audits/appraisals and internal audits.
The position is responsible for:
Provide technical guidance and leadership on items relating to cGMP compliance, including compliance to Corporate Standards, Internal and External audits and all aspects of aseptic processing, such as: sterilization processes, cleaning validation, process media simulations and process interventions.
Direct and manage routine quality review sessions with other site functional leaders for GxP departments.
Ensure aseptic processing activities for the site are in regulatory compliance by pro-actively having detailed process reviews and ensuring the relevant personnel understand the technical processing techniques and practices in detail.
Ensure training systems and practices meet processing requirements and instill the ‘why’ understanding in all personnel employed.
Provide technical review for Change Controls, CAPA's, deviations and investigations as required.
Function as Quality Subject Matter Expert (SME) for aseptic processing at the site.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required nationally and globally.
Regulated Responsibilities (including cGMP and EHS)
Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA
Incumbentwill work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Bachelor’s degree preferably in Microbiology, Chemistry, Chemical Engineering, or related Sciences. Masters in the Sciences is preferred.
Ten (10) years of experiencemanaging a Quality Organization with experience in both pharmaceutical and medical device manufacturing environments.
Ten (10) years of Quality and Technology experience is required. Comprehensive understanding of Aseptic processing required.
Proficient in Microsoft Office.Advanced SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.
FDA, Rx Drug, cGMP, CFR knowledge. Direct experience with FDA and other MOHs inspections and reports.Working knowledge of current pharmaceutical production technologies, quality control procedures, and regulatory requirements.
Essential Knowledge, Skills & Abilities:
Working knowledge of domestic and international regulatory requirements.
Hands on work ethic and must be willing to learn and understand the details of the manufacturing process.
Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems.
Aseptic processing expertise. Has a broad understanding of aseptic processing and compliance/regulations.
Strong problem solving ability and is results driven
Remains calm and self-controlled under pressure. Builds excellent working teams.
Is comfortable and experienced with regulatory agency inspections - including, but not limited to, FDA
Writes and speaks fluently, clearly and concisely. Is effective and confident communicating in a variety of settings both inside and outside of the organization.
Provides clarity of direction and is able to definitively communicate decisions.
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.