Document Control Lead

MANTU GROUP SA; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A global consulting firm in Singapore is seeking a Lead Document Control Specialist to oversee document management activities across operations, engineering, and supply chain. The role requires a minimum of 10 years of experience in a GMP-regulated field and strong leadership abilities. You will ensure compliance with global regulatory standards and lead a team of document control professionals. This position offers opportunities for personal and professional growth while working in a dynamic international environment.

Benefits

Continuous learning opportunities

Diverse international team

Vibrant workplace culture

Qualifications

• Bachelor’s degree in a scientific, technical, or regulatory-related discipline needed.
• Minimum of 10 years of experience in document control in a GMP-regulated environment.
• Experience supporting regulatory audits and inspection readiness programs.

Responsibilities

• Lead and mentor a team of document control specialists.
• Oversee the end-to-end document lifecycle for GxP-relevant documentation.
• Ensure adherence to cGMP and internal SOPs, maintaining audit readiness.

Skills

Leadership

Document control expertise

Regulatory compliance

Attention to detail

Education

Bachelor's degree in a scientific or technical field

Certification in Document Management or Quality Systems

Tools

Electronic Document Management Systems (EDMS)

SAP (QM/PM modules)

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 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.

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 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 toolsfor 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.

WHY AMARIS?

• 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.