[Hiring] Document Control Manager @Celcuity

Role Description

Reporting to the Director, Quality Management Systems, the Document Control Manager will focus on the creation, revision, management, and retirement of Quality Systems documents within the eDMS, and managing controlled records, including historical records, within the controlled library.

• Facilitates the meticulous creation, revision, and retirement of controlled documents in the eDMS, including managing and tracking Document Change Control workflows and participants.
• Management and migration of legacy files into the eQMS.
• Coordinates with the Training Admin to create new or revisions to Training Requirements, learners, quizzes, and other training related to controlled documents.
• Helps eDMS users with the how-to of document creation and revision and works with the QMS Admin to keep relevant document control SOPs and Work Instructions up to date.
• Helps eDMS users find and use current effective documents.
• Facilitates meetings with the QMS Admin and document reviewers to complete content creation or revisions.
• Manages GxP record retention and destruction tasks.
• Facilitates Certified Copy creation and retention.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in the life sciences, chemistry, or related field; or relevant experience.
• Five plus (5+) years of experience in document control in a pharmaceutical company, or a related area.
• Proficiency and experience with electronic document management systems, Veeva strongly preferred.
• Knowledge of version control practices and document lifecycle workflows.
• Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP.
• Strong attention to formatting, process, and metadata tagging; ability to create and correct Styles in Word strongly preferred.
• Document auditing and compliance tracking capabilities.
• Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
• Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
• Attention to detail and ability to manage multiple processes and documentation requirements.
• Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable, and professional attitude.

Benefits

• Anticipated base pay range: $100,000 - $120,000 DOE.
• Eligible for an annual performance incentive bonus and a new hire equity package.
• Various benefits offerings, including medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.