Document Control Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, update, oversee, and phase out Quality Systems documentation within the eDMS.

• Oversee controlled records, including historical documents, in the controlled library.

• Administer and monitor Document Change Control workflows and involved parties.

• Transition legacy documents into the eQMS.

• Collaborate with the Training Administrator on training necessities, learners, assessments, and training related to controlled documents.

• Assist eDMS users with procedures for document creation and revisions.

• Partner with the QMS Administrator to uphold document control SOPs and Work Instructions.

• Aid eDMS users in locating and utilizing current effective documents.

• Organize meetings with the QMS Administrator and document reviewers for the creation and revision of content.

• Oversee GxP record retention and destruction responsibilities.

• Facilitate the creation and retention of Certified Copies.

• Undertake additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in life sciences, chemistry, or a related discipline; or equivalent experience.

• A minimum of 5 years in document control within a pharmaceutical company or a similar field.

• Proficient and experienced with electronic document management systems; Veeva is highly preferred.

• Understanding of version control methods and document lifecycle processes.

• Acquainted with FDA 21 CFR Part 11, ISO 9001, and GMP standards.

• Strong attention to formatting, processes, and metadata tagging; proficiency in creating and adjusting Styles in Word is highly preferred.

• Capable of document auditing and compliance monitoring.

• Advanced skills in MS Office, including Word, Excel, and PowerPoint.

• Exceptional written and verbal communication abilities.

• Strong interpersonal skills.

• Keen attention to detail and the ability to manage multiple processes and documentation needs.

• Strong technical and analytical capabilities.

• Ability to work collaboratively or independently.

• Excellent organizational and prioritization skills.

• Capable of independent and sound decision-making; ability to think critically in a dynamic environment.

• Commitment to continuous improvement.

• Adaptability and willingness to learn in response to business and site demands.

• Positive, approachable, and professional demeanor.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) matching.

• Paid time off (PTO).

• Paid holidays.