Essential Functions

• Manages personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
  
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  
• Implements and maintains the Document Control system and GXP Training program and processes to ensure high quality products and compliance with current GXPs.
  
• Writes and/or implements changes to controlled documents to ensure defined quality objectives are met.
  
• Collaborates with Senior Management teams to ensure optimal tracking of training records.
  
• Designs, develops and delivers high quality and high impact learning products, programs and services that provide functional, GXP and product knowledge for staff to achieve a high level of performance in their jobs.
  
• Evaluates the effectiveness of trainings, implementing modifications when necessary, and monitors training compliance for staff.
  
• Maintains systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems.
  
• Provides administration and troubleshooting for the Electronic Document Management System (EDMS). Provides internal technical support and escalates as appropriate to EDMS vendors technical support.
  
• Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
  
• Manages the document periodic review process.
  
• Manages the collection and maintenance of department metrics.
  
• Provides support with internal and regulatory audits and inspections as required.
  
• Leads project team within functional area, as needed. Participates in cross-functional teams as appropriate for own functional area.
  
• Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
  
• Follows Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.
  
• Performs other related duties and assignments as required and defined by management.
  

Preferred Experience

• At least 8-10 years of document control/training experience in the pharmaceutical/biotech industry or equivalent combination.
  
• At least 4 years of supervisory/personnel management experience.
  
• Preferred Education
  
• Typically a BA/BS or equivalent combination of related education and experience.
  

Preferred Additional Skills

• Strong understanding of the current industry practices, and standards, QA systems principles and applicable regulations including 21 CFR, EU, ICH, etc.
  
• Comprehensive knowledge of Document Control standards, practices, and principles.
  
• Demonstrates strong understanding of adult learning concepts and instructional design, communication and/or education.
  
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  
• Demonstrates excellent verbal, written, and interpersonal communication skills.
  
• Effective time management organizational and planning skills.
  
• Possesses initiative and is proactive.
  
• Must work effectively within teams with rapidly changing priorities.
  
• Builds productive internal and external working relationships.
  
• Demonstrates good coping skills and analytical problem solving skills.
  
• Demonstrates in-depth understanding of system administration and problem resolution.
  
• Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).
  
• Experience with databases and has advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.