Lab Manager, Chemical QA & Regulatory Compliance

POSITION INTRODUCTORY:

This role leads the Lab & Chemical QA and Regulatory Compliance function within the BOL laboratory environment. The incumbent counter-checks chemicals used in flavor formulations, ensures adherence to PerBPOM 18/2025, EU Tobacco Products Directive (TPD) 2014/40/EU, FEMA GRAS, and other applicable multi-jurisdictional standards, and builds scalable QA frameworks across tobacco, food, and beverage lab environments.

Working closely with flavorists, lab personnel, and regulatory stakeholders, the Manager ensures all ingredient and formulation decisions are scientifically sound, legally compliant, and commercially viable.

Success in this role is defined by:

A fully operational QA counter-check system for flavorist formulations

Zero critical findings across PerBPOM 18/2025, FEMA GRAS, and multi-jurisdictional compliance obligations

A standardized, audit-ready ingredient and regulatory database

Governance frameworks consistently adopted across all chemical laboratory functions

Effective cross-functional influence over flavorists, QA, and regulatory teams

Proactive identification and escalation of regulatory risk before it becomes a compliance even

REQUIREMENTS:

PART B: RESPONSIBILITIES & DUTIES

1. Formulation Review & Counter-Checking

• Independently review and counter-check flavor formulations against the regulatory requirements of each intended export market
• Assess formulations against established dosage limits and applicable food, tobacco, and beverage regulatory standards
• Identify ingredient risks, substitution issues, and exposure concerns before formulations proceed to production or regulatory submission
• Maintain a structured, traceable formulation review log with documented sign-off records
• Collaborate with flavorists to resolve compliance gaps without compromising innovation intent

2. Regulatory Compliance & Intelligence

• Ensure compliance with applicable multi-jurisdictional frameworks including:

-PerBPOM 18/2025 and FEMA GRAS

-FDA flavor and food additive regulations

-Tobacco product ingredient requirements

-EU TPD and other APAC and regional standards

• Monitor regulatory changes, emerging restrictions, and enforcement trends across tobacco, food, and flavor sectors
• Translate regulatory updates into timely, actionable compliance directives
• Liaise with external regulatory bodies and industry associations as required

3. QA Framework Development & Standardization

• Design, implement, and continuously improve a QA review framework for chemical and flavor laboratory environments
• Standardize processes for ingredient approval, formulation sign-off, and compliance documentation across all lab functions
• Develop and maintain controlled documents: SOPs, work instructions, review checklists, and regulatory decision trees
• Build a centralized, searchable ingredient and regulatory compliance database to support efficient formulation reviews
• Ensure QA systems are scalable, audit-ready, and aligned with best practices from pharma, food, and tobacco sectors

4. Laboratory Governance & Documentation Control

• Establish and enforce document governance standards across all chemical and regulated laboratories
• Oversee version control, document lifecycle management, and access control for all regulated lab documentation
• Ensure end-to-end traceability of formulation decisions, ingredient usage, and compliance assessments
• Maintain documentation integrity to support internal reviews and external regulatory inspections

5. Analytical Oversight & Instrumentation Governance

• Apply knowledge of analytical instruments (GC, HPLC, GC-MS, ICP-MS) to validate formulation testing methodologies
• Ensure analytical methods are fit-for-purpose, documented, and aligned with regulatory acceptance criteria
• Oversee equipment calibration, qualification records, and maintenance schedules for chemical compliance testing

6. Auditing & Corrective Action Management

• Plan and lead internal audits covering formulation review processes, documentation completeness, and regulatory adherence
• Identify systemic gaps and drive CAPA programs to full closure
• Prepare the organization for external regulatory audits and inspections including FDA and other authority reviews
• Track audit findings, CAPA status, and verify effectiveness to ensure sustainable compliance outcomes

7. Continuous Improvement & Strategic Initiatives

• Lead a 60-day baseline compliance audit upon onboarding to identify and prioritize improvement areas
• Drive digitization of regulatory review processes and leverage available regulatory intelligence tools
• Align QA processes with emerging trends including clean label, natural ingredient demand, and AI-assisted regulatory screening
• Balance process simplification with compliance rigor to support innovation without regulatory exposure

8. Cross-Functional Leadership & Stakeholder Collaboration

• Engage flavorists throughout the formulation development process, not only at final review stage
• Deliver structured training to flavorists and lab staff on regulatory frameworks, dosage limits, and QA requirements
• Align cross-functional stakeholders including R&D, Operations, Regulatory Affairs, and Business Development
• Support change management and organizational adoption of new QA governance practices

9. Other Duties

• Any other ad-hoc assignments as directed by the Head, Document Control & QA or senior leadership

PART C: QUALIFICATIONS & REQUIREMENTS

Educational Background

• Degree in Chemistry, Chemical Engineering, Food Science, or related discipline (essential)
• Master's degree in Chemistry, Regulatory Affairs, or Food Technology is an advantage
• Professional certifications in regulatory affairs, quality management, or food safety are a plus
• 7–10 years of relevant experience across chemical, food/beverage, and/or tobacco industries
• Proven track record in regulatory compliance and QA within multi-regulated environments
• Demonstrated experience counter-checking or reviewing formulations for regulatory acceptability
• Hands-on experience with food and tobacco regulatory frameworks, food additive regulations, and dosage limit assessment
• Exposure to multi-jurisdictional frameworks (FDA, EU TPD, PerBPOM, APAC) strongly preferred
• Pharma or analytical laboratory background is advantageous given its documentation and compliance rigor

Technical Knowledge & Skills

• Strong understanding of flavor chemistry, ingredient functionality, and formulation science
• Working knowledge of analytical instruments: GC, HPLC, GC-MS, ICP-MS
• Proficiency in regulatory databases and compliance tools (FEMA, EFSA, FDA databases)
• Ability to build and maintain controlled documentation systems and QA frameworks
• Familiarity with ISO/IEC 17025, GMP, GLP, ISO 15189, or equivalent quality management standards
• Knowledge of digital regulatory tools and AI-assisted compliance platforms is advantageous

Soft Skills & Leadership Competencies

• Translates complex regulatory information into clear, actionable compliance decisions
• Strong stakeholder management and influencing skills across technical and non-technical audiences
• Proactive, detail-oriented, and ownership-driven
• Resilient and composed under regulatory pressure and tight timelines
• Collaborative; able to guide and upskill flavorists and lab teams
• Adaptable across industry sectors and evolving regulatory landscapes

PART D: SPECIFIC REQUIREMENTS (MANDATORY)

• Demonstrable passion for flavor chemistry and self-directed knowledge of emerging ingredient science, beyond formal training
• Proven ability to build QA systems and compliance frameworks from the ground up in dynamic or evolving environments
• Operates both hands-on and strategically — able to review a formulation while simultaneously driving policy improvements
• Proactively monitors regulatory landscapes; does not wait for alerts
• Track record of zero critical compliance observations or findings in previous roles strongly preferred
• Capable of scenario-based decision-making under pressure, including emergency regulatory restriction events
• Manages competing priorities while maintaining governance discipline in innovation-driven environments

OTHER:

• Working Location: Batam – PT. Blue Ocean Labs
• 5 working days per week