Manager, Global Document Control

Location
Durham, NC, US
Posted
Oct 17, 2020
Ref
5567
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Manager, Global Document Control, is responsible for managing, and providing oversight governance to, the global GxP Document Control system ensuring compliance to quality objectives and regulatory requirements.

Responsibilities
  • Works closely with site-based document control leaders and global customer functions to implement and sustain an optimized Electronic Documentation Management System (EDMS) and associated processes to support global document control processes and operations.
  • Hires, develops and manages the global document control team.
  • Serves the organization as SME for the EDMS and global document control processes and procedures.
  • Ensures a compliant periodic review program for global documents, process reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
  • Oversees the preparation, routing, review, approval, distribution, and archival of new and revised global documents.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests and change workflows support global compliance, timelines and business needs.
  • Works closely with customer functions to support the implementation of an optimized EDMS to support global operations.
  • Develops and provides training for associates on document management system and document management processes and procedures.
  • Leads and supports global implementation and training for projects associated with document management and archival systems.
  • Support audits (internal and external) in order to verify that regulatory and quality requirements are met.
  • Organizes and ensures accurate and reliable filing systems for all paper-based and electronic GxP documents.
  • Other related duties as assigned.

Qualifications
  • Bachelor's degree in Life Sciences with 5 years of technical writing/document control experience in the pharmaceutical/biotech industry
  • Experienced and quality-focused with the ability to work closely with site-based document control leaders and global customer functions to implement and sustain an optimized Electronic Documentation Management System (EDMS) and associated processes to support global document control processes and operations.
  • Demonstrable strategic and critical thinking skills.
  • Significant experience with leading implementation and sustainability of Electronic. Document Management Systems, including workflow development and optimization.
  • Experience developing and managing a document control team.
  • Experience with internal/external GxP audits.
  • Excellent knowledge of understanding of applicable GxP regulations.
  • Works under minimal supervision; requires a high level of independence.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy and efficiency.
  • Effective written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Possesses initiative and is proactive, self-starter.
  • Proficient with the Microsoft Office suite (ie, Word, Excel, Visio, PowerPoint, etc.) and Adobe.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-MG1