Job Description:
Position Summary:
The Senior Document Control Specialist is responsible for overseeing the management, organization, and maintenance of all controlled documents within the company’s quality management system (QMS). This role ensures compliance with regulatory requirements, company policies, and industry standards, supporting the efficient operation of the pharmaceutical development and manufacturing processes.
Key Responsibilities:
Document Management:
- Manage the lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival
- Ensure documents are accessible, accurate, and up-to-date within the electronic document management system (EDMS).
- Coordinate with cross-functional teams to ensure timely review and approval of documents.
- Ensure all document control activities comply with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and per Vertex Procedures.
- Maintain audit readiness by ensuring documents are in a state of compliance and available for internal and external audits.
- Identify and implement process improvements to enhance the efficiency and effectiveness of the document control system.
- Develop and maintain document control procedures, work instructions, and training materials.
- Provide training and support to employees on document control processes.
- Act as a subject matter expert for document control during audits and inspections.
- Generate and analyze document control metrics and reports to monitor performance and identify areas for improvement.
- Present findings to management and recommend corrective actions as needed.
Qualifications:
- Bachelor’s degree in a related field (e.g., Life Sciences, Quality Assurance, or Regulatory Affairs).
- Minimum of 5-7 years of experience in document control within the pharmaceutical, biotechnology, or medical device industry.
- Strong knowledge of cGMP, GDP, and regulatory requirements (e.g., FDA, EMA).
- Proficiency in using electronic document management systems and other relevant software.
- Excellent organizational, communication, and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced, dynamic environment.
- Detail-oriented with a commitment to quality and accuracy.
Preferred Qualifications:
- Certification in Document Control or Quality Management
- Experience with lean or continuous improvement methodologies.
- Familiarity with global regulatory requirements and international document control standards.
