Job Summary:

The Documentation Control Supervisor is responsible for overseeing the document control process, ensuring that all company documentation is managed, organized, and maintained in compliance with internal standards and regulatory requirements. This role involves supervising a team of document control specialists, coordinating with various departments to facilitate document workflows, and implementing and improving document control systems.

Job Responsibilities:

• Lead and manage the document control team, providing guidance, training, and performance evaluations.
• Allocate resources and assign tasks to ensure timely processing and distribution of documents.
• Oversee the creation, review, revision, and archiving of controlled documents, including SOPs, manuals, specifications, and records.
• Ensure proper version control and document tracking using document management systems (DMS).
• Ensure all documentation meets regulatory and company standards.
• Maintain compliance with industry regulations (e.g., ISO, FDA, GMP) and internal policies.
• Coordinate and support internal and external audits related to document control.
• Manage and maintain document control software and systems.
• Develop and implement improvements to document control processes and systems.
• Provide training to staff on document control procedures and systems.
• Serve as primary point of contact for document-related inquiries and requests.
• Collaborate with various departments (e.g., Quality, Manufacturing, R&D) to ensure document accuracy and completeness.
• Facilitate document review meetings and provide regular status updates to management.
• Generate reports on document control activities and metrics.
• Analyze data to identify trends and areas for improvement.
• Stay updated on industry best practices and emerging trends in document control.
• Proactively seek opportunities to enhance the efficiency and effectiveness of the document control process.
• Conduct all activities in compliance with GMP, Safety and Employment policies, corporate and regulatory requirements.
• Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:
  • Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes;
  • Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy;
  • Effectively managing performance for direct reports according to the Performance Management Program,
  • Attracting and retaining talent based on our talent management framework;
  • Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions;
  • Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
  • Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
  • Works as a member of a team to achieve all outcomes;
  • Leads with a mindset that respects all cultural dimensions;
  • Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
  • Delivers all work in support of our Values of Innovate, Excel, and Evolve;
  • All other duties as assigned.

• Job Requirements
• Education
• Bachelor of Science Degree in Applied Sciences and/or Pharmaceutical Engineering

• Experience
• Minimum 7 years of experience in a GMP-regulated industry, 4 years of which has been spent in Quality Operation