Director, Quality Operations

Location
Cambridge, MA, United States
Posted
Jan 20, 2019
Ref
R-01916
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Director, Quality Operations

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Position Overview:

Deploy and maintain the Quality Management System of the US commercial affiliate, ensuring oversight and release of US commercial product to trade. The life-cycle management of relevant GxP procedures, policies and work instructions. Relevant GxP personnel are trained and training records are maintained. CAPA and change control. Assist in the management of call center operations and cases such as product quality complaints and medical information reports.

This role is also responsible for (but not limited to) establishing and maintaining relationships with manufacturing and distribution channels through the development and maintenance of Quality Technical Agreements and ensuring compliance with policies and procedures relevant to appropriate distribution of commercial drug.

Job Responsibilities:
  • Work in collaboration with Global Quality and Technical Operations to ensure the US commercial affiliate of Ipsen operates according to global (and local) GMP and GCP/PV standards
  • Responsible for providing quality and technical support to the US affiliate, and responsible for managing local procedures, policies and work instructions through the company's electronic repository.
  • Provide technical assistance, leadership, and support for special projects and teams as assigned.
  • Reviewing certificates of analysis and compliance for accuracy and compliance with registered licenses, and releases commercial drug product into US market
  • Reviews shipping records and temperature traces for all international and national shipments of commercial product in the US
  • Maintains a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GMP/GDP/GCP/PV regulations; disseminates Quality culture and awareness across all functions
  • Establishes systems to assure compliance with domestic and international cGDP regulations both at the local Ipsen office and at its contractors
  • Works with Pharmacovigilance to review Safety Data Exchange Agreements as required and communicates complaint issues to the Central Department of Pharmacovigilance and the Corporate Quality and Safety Evaluation Board as required
  • Reviews and approves all SOPs and establishes approval workflows
  • Manage system for GxP training and record retention for applicable personnel

Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff

Requirements:
  • Four-year degree in a scientific discipline required or related experience
  • Minimum of 10 years of experience in a quality operations position within pharmaceutical quality compliance/quality assurance
  • Trained and qualified auditor with extensive experience in conducting both internal and external audits and CAPA management
  • Experience in writing and implementing compliance policies, procedures and quality systems is essential
  • Strong background in regulatory compliance management
  • Strong background in establishing working relationships and establishing Quality Agreements with third parties involved in research and contract manufacturing organizations or drug distribution
  • Experience managing document control systems, as well as Electronic Data Management systems like Trackwise® and preferable experience with SAP or other electronic inventory control system
  • Role requires an inherent interest in compliance and quality development of self and of the organization


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.