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 formulationsZero critical findings across PerBPOM 18/2025, FEMA GRAS, and multi-jurisdictional compliance obligationsA standardized, audit-ready ingredient and regulatory databaseGovernance frameworks consistently adopted across all chemical laboratory functionsEffective cross-functional influence over flavorists, QA, and regulatory teamsProactive identification and escalation of regulatory risk before it becomes a compliance even

REQUIREMENTS:PART B: RESPONSIBILITIES & DUTIES1. Formulation Review & Counter-CheckingIndependently review and counter-check flavor formulations against the regulatory requirements of each intended export marketAssess formulations against established dosage limits and applicable food, tobacco, and beverage regulatory standardsIdentify ingredient risks, substitution issues, and exposure concerns before formulations proceed to production or regulatory submissionMaintain a structured, traceable formulation review log with documented sign-off recordsCollaborate with flavorists to resolve compliance gaps without compromising innovation intent2. Regulatory Compliance & IntelligenceEnsure 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 standardsMonitor regulatory changes, emerging restrictions, and enforcement trends across tobacco, food, and flavor sectorsTranslate regulatory updates into timely, actionable compliance directivesLiaise with external regulatory bodies and industry associations as required3.

QA Framework Development & StandardizationDesign, implement, and continuously improve a QA review framework for chemical and flavor laboratory environmentsStandardize processes for ingredient approval, formulation sign-off, and compliance documentation across all lab functionsDevelop and maintain controlled documents: SOPs, work instructions, review checklists, and regulatory decision treesBuild a centralized, searchable ingredient and regulatory compliance database to support efficient formulation reviewsEnsure QA systems are scalable, audit-ready, and aligned with best practices from pharma, food, and tobacco sectors4. Laboratory Governance & Documentation ControlEstablish and enforce document governance standards across all chemical and regulated laboratoriesOversee version control, document lifecycle management, and access control for all regulated lab documentationEnsure end-to-end traceability of formulation decisions, ingredient usage, and compliance assessmentsMaintain documentation integrity to support internal reviews and external regulatory inspections5. Analytical Oversight & Instrumentation GovernanceApply knowledge of analytical instruments (GC, HPLC, GC-MS, ICP-MS) to validate formulation testing methodologiesEnsure analytical methods are fit-for-purpose, documented, and aligned with regulatory acceptance criteriaOversee equipment calibration, qualification records, and maintenance schedules for chemical compliance testing6.

Auditing & Corrective Action ManagementPlan and lead internal audits covering formulation review processes, documentation completeness, and regulatory adherenceIdentify systemic gaps and drive CAPA programs to full closurePrepare the organization for external regulatory audits and inspections including FDA and other authority reviewsTrack audit findings, CAPA status, and verify effectiveness to ensure sustainable compliance outcomes7. Continuous Improvement & Strategic InitiativesLead a 60-day baseline compliance audit upon onboarding to identify and prioritize improvement areasDrive digitization of regulatory review processes and leverage available regulatory intelligence toolsAlign QA processes with emerging trends including clean label, natural ingredient demand, and AI-assisted regulatory screeningBalance process simplification with compliance rigor to support innovation without regulatory exposure8. Cross-Functional Leadership & Stakeholder CollaborationEngage flavorists throughout the formulation development process, not only at final review stageDeliver structured training to flavorists and lab staff on regulatory frameworks, dosage limits, and QA requirementsAlign cross-functional stakeholders including R&D, Operations, Regulatory Affairs, and Business DevelopmentSupport change management and organizational adoption of new QA governance practices9.

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

PART C: QUALIFICATIONS & REQUIREMENTSEducational BackgroundDegree in Chemistry, Chemical Engineering, Food Science, or related discipline (essential)Master’s degree in Chemistry, Regulatory Affairs, or Food Technology is an advantageProfessional certifications in regulatory affairs, quality management, or food safety are a plus7–10 years of relevant experience across chemical, food/beverage, and/or tobacco industriesProven track record in regulatory compliance and QA within multi-regulated environmentsDemonstrated experience counter-checking or reviewing formulations for regulatory acceptabilityHands-on experience with food and tobacco regulatory frameworks, food additive regulations, and dosage limit assessmentExposure to multi-jurisdictional frameworks (FDA, EU TPD, PerBPOM, APAC) strongly preferredPharma or analytical laboratory background is advantageous given its documentation and compliance rigor

Technical Knowledge & SkillsStrong understanding of flavor chemistry, ingredient functionality, and formulation scienceWorking knowledge of analytical instruments: GC, HPLC, GC-MS, ICP-MSProficiency in regulatory databases and compliance tools (FEMA, EFSA, FDA databases)Ability to build and maintain controlled documentation systems and QA frameworksFamiliarity with ISO/IEC 17025, GMP, GLP, ISO 15189, or equivalent quality management standardsKnowledge of digital regulatory tools and AI-assisted compliance platforms is advantageousSoft Skills & Leadership CompetenciesTranslates complex regulatory information into clear, actionable compliance decisionsStrong stakeholder management and influencing skills across technical and non-technical audiencesProactive, detail-oriented, and ownership-drivenResilient and composed under regulatory pressure and tight timelinesCollaborative; able to guide and upskill flavorists and lab teamsAdaptable across industry sectors and evolving regulatory landscapesPART D: SPECIFIC REQUIREMENTS (MANDATORY)Demonstrable passion for flavor chemistry and self-directed knowledge of emerging ingredient science, beyond formal trainingProven ability to build QA systems and compliance frameworks from the ground up in dynamic or evolving environmentsOperates both hands-on and strategically — able to review a formulation while simultaneously driving policy improvementsProactively monitors regulatory landscapes; does not wait for alertsTrack record of zero critical compliance observations or findings in previous roles strongly preferredCapable of scenario-based decision-making under pressure, including emergency regulatory restriction eventsManages competing priorities while maintaining governance discipline in innovation-driven environmentsOTHER:Working Location: Batam – PT. Blue Ocean Labs5 working days per week