Manager, Document Control, Training

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

📋 Description

• Oversee daily operations while leading ongoing enhancement initiatives within the Quality Management System (QMS), which encompasses Document Change Control, Document Control, and Training to ensure GxP compliance across various domains.

• Accountable for supervising Document Control tasks pertaining to documents utilized in GxP operations, including those related to manufacturing, clinical, regulatory, and product quality, along with archiving functions.

• Facilitate and support the development, revision, and retirement of GxP controlled documents, which includes reporting, periodic reviews, and trend analysis.

• Manage ACE administration, including the eDMS (document change requests, training), and oversee records management.

• Perform system administration tasks such as the creation, monitoring, and maintenance of Users, Groups, Roles, and Entities (e.g., workflows) within the ACE system.

• Ensure proper archival of GxP records in the ACE system by adhering to the appropriate ACE workflow for document storage.

• Assist in the onboarding process for new employees within the Quality Management System.

• Revise document control procedures to maintain compliance with GDP (Good Documentation Practices) and applicable GxP regulations and standards concerning document review, approval, release, retrieval, storage, and retention.

• Collaborate with cross-functional teams to help standardize practices within and across quality systems by drafting SOPs and quality processes.

• Measure and analyze metrics related to change requests and quality records.

• Provide input and support for inspection readiness activities.

• Aid in investigating and addressing actions pertaining to audit findings.

• Serve as the subject matter expert for the document change control system and training program for Secura Bio, Inc., during both internal and external audits.

• Possess a comprehensive understanding of the processes, procedures, and systems employed to complete the team's work, along with familiarity with related concepts in other areas within the function.

• May participate in vendor management tasks and Quality Management Review (QMR).

• Other responsibilities as assigned.

⛳️ Requirements

• A minimum of 8 years of relevant and progressive experience in the implementation and management of QA Quality Systems, QA Documentation processes, and Good Documentation Practices within the drug, biopharmaceutical, or medical device sectors.

• Proficient in using computers and related software (MS Windows, MS Office, PDF generation, electronic security implementation, and hosted server applications).

• Experienced with electronic document control systems that comply with FDA 21 CFR Part 11.

• Solid understanding of FDA regulations and ICH guidelines for drugs, biologics, and devices, as well as international device standards.

• Knowledgeable in process design and implementation, change control, auditing, and document management systems.

• Proven detail-oriented, with strong organizational, management, and communication skills.

• Capable of managing multiple tasks and prioritizing projects to meet established goals and objectives.

• Able to balance and prioritize various projects, duties, and assignments effectively.

• Adaptable to a fast-paced, team-oriented work environment.

• Skilled in fostering cooperation and teamwork among team members.

• Proficient in analyzing, troubleshooting, and resolving issues as they arise.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.