Manager, GMP Training

Location
San Diego, California
Posted
Apr 09, 2018
Ref
164
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Manager, GMP Training will oversees the development, implementation and maintenance of the GMP Training program in compliance with current Good Manufacturing Practices (GMP) and regulatory requirements for Pacira’s Science Center Campus and Headquarters. 

  • Provide exceptional customer service to Pacira’s internal and external customers in all assigned tasks and foster a GMP compliance culture.
  • Manage the development and administration of the training processes and system to enable Pacira, GMP-impact, personnel to attain/maintain compliance with all GMP training requirements.
  • Collect, analyze and report on training key performance indicators for the GMP training program.
  • Control and maintain inventory over the storage and movement of personnel training records stored in the Document Control Vault (hardcopy records) and the Learning Management System (electronic records) in compliance with regulatory requirements and internal record retention policies.
  • Liaise across the business to partner, educate and support internal customers in the setup and administration of departmental and job-function curriculum, management of training for consultants/contractors, and compliance to assigned requirements.
  • Assess training needs (metrics, surveys, interviews) to develop and deliver appropriate training on a perpetual basis on current GMP topics as well as Quality Systems tools and methodologies.
  • Administer the internal Train-the-Trainer program.
  • Write, review and revise as necessary GMP Training policies and procedures.
  • Support regulatory inspections and partner audits.
  • Other duties as assigned.

The qualified candidates will possess the following:

  • Four-to-six years of relevant pharmaceutical industry, Quality Assurance and/or GMP Training, experience.
  • Demonstrated managerial experience in Training and/or Quality Assurance.
  • BS/BA degree in scientific, education, or teaching discipline or equivalent experience.

 

  • Must have a strong understanding of Quality Systems and GMP.
  • Ability to organize, analyze, plan, and develop the GMP Training function.
  • Ability to lead staff and manage GMP Training activities in a fast paced environment.
  • Ability to manage multiple responsibilities with a high degree of self-motivation.
  • Ability to breakdown and convey complex material in simplistic terms using a variety of instructional techniques or formats for educating and training staff at all job levels in the organization.
  • Strong communication, presentation, interpersonal, and organizational skills.
  • Proficiency in Microsoft Excel, PowerPoint, Word, and Adobe Acrobat applications.
  • Prior experience with ComplianceWire and/or MasterControl desirable.
  • Flexibility to work varying schedules to support occasional weekend, holiday and off shift work hours.