Document Control Lead

MANTU INTERNATIONAL PTE LTD; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

A leading consulting firm in Singapore seeks an experienced Lead Document Control Specialist to oversee all document control activities, ensuring compliance with regulatory standards. This role requires strong leadership skills and a deep understanding of document management in a GMP-regulated environment. You will lead a team, manage document lifecycle processes, and collaborate closely with quality and regulatory teams. The ideal candidate has extensive experience with EDMS platforms and a solid track record in supporting regulatory audits.

Benefits

Professional development opportunities

Diverse international team

Dynamic and vibrant work culture

Qualifications

• Minimum of 10 years of experience in document control within a GMP-regulated environment.
• At least 4 years in a lead or supervisory role.
• Proven track record with regulatory audits.
• Experience with generative AI tools is a plus.

Responsibilities

• Lead and mentor a team of document control specialists.
• Oversee the end-to-end document lifecycle.
• Serve as the primary administrator for the Electronic Document Management System.
• Collaborate with various teams to standardize documentation practices.

Skills

Leadership

Document Control

Attention to Detail

Regulatory Compliance

Data Analysis

Communication

Education

Bachelor’s degree in a scientific, technical, or regulatory-related discipline

Certification in Document Management or Quality Systems

Tools

EDMS platforms (MasterControl, DocuWare, Veeva Vault)

SAP (QM/PM modules)

Microsoft Office Suite

Job description

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!

Job description

ABOUT THE JOB

As aLead 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 mentora team of document control specialists, ensuring consistent application of policies, procedures, and compliance standards.
• Oversee theend-to-end document lifecycle—creation, review, approval, distribution, revision, archival, and destruction—for all GxP-relevant documentation.
• Serve as theprimary administrator and SMEfor the Electronic Document Management System (EDMS), including configuration, workflow design, user access management, and system validation support.
• Ensure strict adherence tocGMP, 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 maintaindocument control metrics and KPIs; analyze trends and drive corrective actions to address gaps.
• Leadinternal and external audit responsesrelated to documentation, including preparation, evidence gathering, and CAPA implementation.
• Championdigital transformation initiatives, including EDMS upgrades, integration with SAP/QMS/LIMS, and adoption of automation tools (e.g., AI-driven metadata tagging, OCR).
• Author and reviseglobal 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.

ABOUT YOU

• 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 yearsof progressive experience in document control or records management within aGMP-regulated environment(pharmaceuticals, biotechnology, medical devices).
• At least4 years in a lead, supervisory, or senior specialist capacity, with direct experience managing teams or projects.
• Proven track record supportingregulatory audits (FDA, EMA, etc.)and participating in inspection readiness programs.
• Extensive hands-on experience withEDMS platforms(e.g., MasterControl, DocuWare, Veeva Vault, SharePoint with validation controls).
• Strong working knowledge ofSAP (QM/PM modules), LIMS, QMS, and electronic signature workflows.
• Familiarity withcomputer system validation (CSV)and change control processes is essential.
• Experience withgenerative AI toolsfor content summarization, metadata extraction, or process automation is a strong plus.
• Exceptional leadership, coaching, and team development abilities.
• High level ofattention to detail, organizational rigor, and ability to manage multiple priorities under tight deadlines.
• Advanced proficiency inMicrosoft Office Suite(Word, Excel, Visio, PowerPoint), Adobe Acrobat, and collaboration tools (e.g., Teams, Confluence).
• Excellentwritten 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.

WHY AMARIS?

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

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.