Document Control Manager, Facilities

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need. 
  • Provide an environment for employees to reach their fullest potential. 

Our values:

  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Overview

We have an opportunity for an Document Control Manager to join the AskBio team in our Research Triangle Park (Durham), NC location and be part of our continued success! The Document Control Manager will assist in the management of capital projects and day-to-day operation of AskBio facilities.

Responsibilities

  • Work with cross-functional management to ensure documentation is completed and adhering to Good Documentation Practices (GDP) in a timely and accurate manner.
  • Supervises a team in GDP including equipment files and project associated files (e.g., maintenance records, calibration records, validation records, commissioning records, and other documents as applicable).
  • Manage and maintain filing system of equipment records and all other documents for support of GLP activities utilizing DSI asset management software.
  • Provide support for DSI asset management system for internal/external audits as needed.
  • Applicant shall receive, review, and file documentation for IQ/OQ, equipment calibrations, equipment startup, and construction document sets on each assigned project by utilizing MS SharePoint and DSI asset management software packages.
  • Receive laboratory equipment calibration reports and record within the Asset Management system.
  • Assist as needed with quality system processes, including deviations, corrective and preventive actions, etc.
  • Compliance with established Company and departmental policies and procedures, objectives, quality assurance program, safety, and environmental standards.
  • Develop, maintain, and report to senior management Quality Metrics for document control.
  • Assist with setup and maintenance of equipment calibration schedule and vendor management.
  • Assist with Rees Scientific lab monitoring system as needed.
  • Work with engineering team to implement safety initiatives to ensure site compliance.

Required Education and Experience

  • Bachelor’s degree.
  • 5+ years experience operating in a quality-driven GLP environment.

Preferred Experience and Skills

  • Minimum of one-year supervisory experience in QA document control.
  • Prior pharma, laboratory, or facilities experience.
  • Self-motivated, organized, individual capable of working independently as well as a team contributor.
  • Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally.
  • Demonstrated ability to handle multiple competing priorities.
  • Ability to establish and maintain effective working relationships with coworkers and managers.
  • Experience with engineering, architectural, and construction documents (i.e., maps, drawings, technical specifications, etc.)
  • Proficient using a PC and working with Microsoft Office Suite (Word, Excel and PowerPoint).

 

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at talent@askbio.com.