puestos de Scientific en Singapur

Job description

As a Lead Document Control Specialist , you will provide strategic oversight and leadership in the management of all document control activities across operations, engineering, supply chain, and quality functions. You will ensure compliance with current Good Manufacturing Practices (cGMP), data integrity principles (ALCOA+), and global regulatory standards (e.g., FDA, EMA, PIC / S). This role plays a critical part in maintaining audit readiness and driving continuous improvement across document management systems and processes.

You will lead a team of document control professionals, define best practices, and serve as the subject matter expert (SME) for electronic and paper-based documentation systems. The position requires deep technical knowledge, strong leadership capabilities, and experience supporting regulatory inspections and quality system audits.

• Lead and mentor a team of document control specialists, ensuring consistent application of policies, procedures, and compliance standards.
• Oversee the end-to-end document lifecycle —creation, review, approval, distribution, revision, archival, and destruction—for all GxP-relevant documentation.
• Serve as the primary administrator and SME for the Electronic Document Management System (EDMS), including configuration, workflow design, user access management, and system validation support.
• Ensure strict adherence to cGMP, data integrity (Annex 11, 21 CFR Part 11) , and internal SOPs; maintain systems in a state of perpetual audit readiness.
• Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams to standardize documentation practices and improve cross-functional efficiency.
• Develop, implement, and maintain document control metrics and KPIs ; analyze trends and drive corrective actions to address gaps.
• Lead internal and external audit responses related to documentation, including preparation, evidence gathering, and CAPA implementation.
• Champion digital transformation initiatives , including EDMS upgrades, integration with SAP / QMS / LIMS, and adoption of automation tools (e.g., AI-driven metadata tagging, OCR).
• Author and revise global document control procedures and templates ; conduct training sessions for new and existing personnel.
• Evaluate emerging technologies and industry best practices to continuously enhance the document management framework.

• Bachelor’s degree in a scientific, technical, or regulatory-related discipline (e.g., Life Sciences, Engineering, Information Management).
• Certification in Document Management, Quality Systems, or related field (e.g., CQI, IRCA, AIIM) is highly desirable.
• Minimum of 10 years of progressive experience in document control or records management within a GMP-regulated environment (pharmaceuticals, biotechnology, medical devices).
• At least 4 years in a lead, supervisory, or senior specialist capacity , with direct experience managing teams or projects.
• Proven track record supporting regulatory audits (FDA, EMA, etc.) and participating in inspection readiness programs.
• Extensive hands‑on experience with EDMS platforms (e.g., MasterControl, DocuWare, Veeva Vault, SharePoint with validation controls).
• Strong working knowledge of SAP (QM / PM modules), LIMS, QMS , and electronic signature workflows.
• Familiarity with computer system validation (CSV) and change control processes is essential.
• Experience with generative AI tools for content summarization, metadata extraction, or process automation is a strong plus.
• Exceptional leadership, coaching, and team development abilities.
• High level of attention to detail , organizational rigor, and ability to manage multiple priorities under tight deadlines.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Adobe Acrobat, and collaboration tools (e.g., Teams, Confluence).
• Excellent written and verbal communication skills , with the ability to interact effectively across departments and with external auditors.
• Strong analytical mindset with experience using data to drive process improvements.
• Change agent with a commitment to operational excellence and compliance innovation.

At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact. Here’s what you can expect when you join our dynamic community :

• Global Diversity : Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
• Trust and Growth : With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
• Continuous Learning : Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
• Vibrant Culture : Enjoy a workplace where energy, fun, and camaraderie come together through afterworks, networking events, and more.
• Meaningful Impact : Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.

Equal Opportunity