Training Specialist Principal Job Listing at Genzyme Corporation in Allston, MA

Biotechnology, Pharmaceutical

Training Specialist Principal-30449

Description

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

The Training Specialist Principal (Quality Systems) is the primary contact and responsible person for representing the Allston Landing Quality Organization in the review and approval of site training materials.

The position is responsible for providing guidance and oversight regarding GMP compliance for training of all personnel who perform duties that have the potential to affect the quality of processes and products at the Allston Landing Facility.

The position provides instructor led training to the Quality Systems department as required, as well acting as the department administrator for the Learning Management System (LMS) and supporting the department in obtaining, monitoring, and reporting on training metrics, and managing training compliance for the department.

The position reviews and approves site GMP related training procedures, in accordance with applicable drug and biologic regulations and company standards, and supports the site implementation of Learning Management System projects such as LMS upgrades.

This position will report to the Senior Director, Quality Systems. He/she will work closely with the Development and Training department to build compliant training materials processes and ensure that the sites training deliverables and milestones are delivered on time.

Key Role Functions:

• Reviews and approves all site training materials for Quality.
  
• Reviews and approves site GMP related training procedures for Quality.
  
• Delivers GMP Training for Quality Systems and evaluates training effectiveness
  
• Acts as a Training Coordinator for Quality Systems
  
• Serves as a training representative for Quality with other departments, and as a project resource for LMS projects.
  
• Provides technical support to Quality for LMS, includes providing system reports and data in a readable format
  
• Serves as a liaison between Quality LMS users system administrators. Supports LMS change control upgrade activities
  
• Works with internal departments, and other sites to ensure Quality training projects are completed in a timely manner to support site priorities and maintain GMP training in a compliant state.
  
• Monitor Quality Systems training activities to ensure compliance with site goals, and company and regulatory standards.
  
• Support assigned CD teams to ensure timely and compliant implementation of the Consent Decree Work Plan.
  

Qualifications
BASIC QUALIFICATIONS:

• Bachelor's Degree with 5+ years of pharmaceutical/biotechnology industry experience or appropriate equivalencies based on USCIS guidelines
• 3+ years of experience in Quality Assurance including training and hands-on experience working with electronic knowledge management systems
• Thorough knowledge of FDA, EU and other global GMP guidance and regulations
• Proven leadership and mentoring skills
• Experience with a Quality oversight operational role and responsibility
• Demonstrated ability to influence cross-functionally
• Demonstrated exemplary oral and written communication skills

PREFFERED QUALIFICATIONS:

• Bachelor's degree in Instructional Design, Training or Education
• Familiarity with one or more of the following areas:
  • Design and implementation of Computer Based Training, Instructor Led Training, eLearning systems, and training Assessments. Regulatory Compliance
  • Instructional Design
  • Learning Management System administration
  • Biopharmaceutical manufacturing processes and equipment
  • Electronic Document

SPECIAL WORKING CONDITIONS:

• Ability to gown and gain entry to manufacturing areas.

Job : Training
Primary Location : United States-Massachusetts-Allston

Job Posting : May 15, 2013

Shift : Day Job
Job Type : Regular
Employee Status : Regular