Allergan Associate Director, Quality Compliance in Waco, Texas

Associate Director, Quality Compliance

Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/5501/other-jobs-matching/location-only

May 25, 2018Post Date

180244Requisition #

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 Description

This position is responsible for managing the quality continuous improvement program, to ensure that the site is maintained in a state of evergreen compliance as it relates to FDA Code of Federal Regulations, European Regulations, and other Ministry of Health regulatory requirements.

Main Areas of Responsibilities

  • Hosting FDA and other Ministry of Health Regulatory Inspections at the site and managing the response and remediation activities.

  • Managing the internal audit program

  • Interpret regulations and standards and serve as an advisor to Waco Sr. Staff on FDA/EU/ROW GMP regulations and guidance.

  • Establishing and maintaining a risk management program in accordance with the ICH Q8, Q9 and Q10, life cycle model

  • Manage the site cGMP and Aseptic training program

  • Participate in product investigations related to Field Alerts and other investigations as required.

  • Coordinate the annual Mock Recall program and coordinate recalls as necessary

  • Review SOPs, regulatory filings, and commitments for compliance with regulations.

  • Maintain metrics, develops trend data of audit/inspection observations and CAPAs and communicate results expediently to applicable groups.

  • Assists with Vendor audits and supports Global Quality teams as needed.

  • Review SOPs, regulatory filings, and commitments for compliance with regulations.

Requirements

  • Strong knowledge of regulatory requirements and aseptic manufacturing processes under cGMP and QSR guidance and knowledge of pharmaceutical regulations, quality systems, and regulatory audits.

  • Sterile manufacturing experience is required

  • 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.

  • Quality System knowledge (FDA/GMP, ISO 13485/13488, non US Agency experience for example HPRA and PMDA).

  • Proven lead auditor skills.

  • Ability to communicate effectively with all levels of the organization.

  • Ability to effect change without direct responsibility for all levels of the organization.

  • Ability to thrive in a team environment.

  • Training with problem solving methods such as KTA’s, HACCP, or equivalent.

Preferred Qualifications:

  • Minimum of 10 years’ experience in Quality Assurance. Results oriented leadership in multiple Quality or Operations roles preferred.

  • Strong computer knowledge is required including Microsoft Office and the ability to learn relevant internal computer systems. QMS (Trackwise), LIMS, SAP highly preferred.

  • Strong computer knowledge is required including Microsoft Office and the ability to learn relevant internal computer systems. QMS (Trackwise), LIMS, SAP highly preferred. Education

  • Bachelor’s degree in the Sciences, Engineering or related field. Master’s degree or Ph.D. in related field preferred.

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.