Company Profile: The company is a leading manufacturer of preservatives, UV filters, skincare and haircare active ingredients, nutraceuticals and natural extracts for the personal care and pharmaceutical industries.

Supplying to over 60 countries and more than 1,000 customers globally, including multinational organizations.

Candidate Profile.

The ideal candidate will be an experienced Quality leader with deep technical knowledge of API/pharmaceutical quality systems and demonstrated experience in managing multi-site quality operations and global regulatory interactions.

Qualifications.

- Qualification Required Preferred Education B.Sc + M.Sc in Chemistry (or equivalent degree) Ph.D in Chemistry or related discipline; additional certifications in Quality/Regulatory (e.g., Six Sigma, Lead Auditor)

- Experience Minimum 20 years in Quality function within API / Pharmaceutical manufacturing, with progressive responsibility

- Experience with multi-site corporate QA leadership, exposure to personal care ingredients/manufacturing and working with multinational customers

- Regulatory & Audit Experience Hands-on experience managing regulatory inspections (USFDA, MHRA, WHO, EUGMP) and closing observations

- Direct experience leading USFDA inspections and complex remediation programs across sites Leadership & People Management Proven track record of leading QA teams, mentoring senior QA/plant QA leaders and implementing governance

- Experience in succession planning, competency matrices and cross-functional governance at corporate level Technical & Quality Systems Strong knowledge of GMP, data integrity, QMS, CAPA, validation and risk tools (FMEA, Fishbone, 5 Why)

- Experience in QMS digital transformation, Six Sigma/Lean initiatives and advanced quality analytics Present Role Currently heading Quality Department (Corporate / Plant QA)

Position Objective.

To lead Corporate Quality Assurance for API manufacturing units by ensuring compliance with global regulatory standards (USFDA, MHRA, WHO, EUGMP, GMP, ISO), building a quality-driven culture, and safeguarding product quality, patient safety, and the regulatory reputation of the organization across multiple sites.

Key Responsibilities (Corporate CQA).

Overview: Lead the corporate QA function to ensure regulatory compliance, robust quality systems, consistent product quality, and continuous improvement across multiple API sites.

Responsibilities are grouped for quick scanning.

Regulatory Compliance:

- Ensure adherence to international regulations (GMP, GLP, ISO, FDA, EUGMP, WHO) across all sites.

- Monitor regulatory changes and drive timely policy and procedural updates.

- Coordinate regulatory submissions and manage responses during inspections.

Audits & Inspections:

- Plan and execute internal audits and readiness reviews for external inspections (USFDA, WHO, EUGMP, MHRA).

- Lead interactions during regulatory audits and oversee closure of observations with effectiveness checks.

- Maintain inspection readiness and manage remediation programs where required.

Quality Systems & Policy:

- Develop, standardize and implement Quality Manuals, SOPs and governance frameworks across sites.

- Drive QMS standardization, digitalization initiatives and ensure data integrity across systems.

- Provide training and oversight to ensure consistent application of policies.

Risk Management & CAPA:

- Lead risk assessments (FMEA, Fishbone, 5 Why) and scientific root-cause investigations.

- Oversee CAPA lifecycle to ensure timely, effective corrective and preventive actions.

- Track and reduce repeat deviations and critical quality risks.

Continuous Improvement & Performance:

- Champion Kaizen, Lean and Six Sigma initiatives to improve processes and reduce variability.

- Drive process optimization, quality analytics and QMS digital transformation projects.

- Benchmark industry best practices and implement measurable improvements.

Documentation, Reporting & Release:

- Ensure integrity and completeness of QA documentation, electronic records and audit trails.

- Maintain complaint, change control and deviation records; prepare periodic quality reports for Senior Management/Board.

- Provide corporate recommendation for batch release and hold authority to stop critical shipments.

Leadership & Stakeholder Management:

- Lead, coach and develop the Corporate QA team and plant QA leaders; implement succession planning and competency matrices.

- Foster cross-functional governance with Production, Regulatory Affairs, QC, R&D, EHS, Supply Chain and Engineering.

- Represent Corporate QA in senior management forums and drive quality culture across the organization.

KRAs (Key Result Areas):

- Regulatory Compliance: 100% compliance to global regulatory guidelines; zero critical data integrity issues.

- Audit Performance: Completion of internal audits vs plan; high success rate in regulatory audits; timely closure of observations.

- CAPA & Risk Management: CAPA effectiveness >95%; reduction in repeat deviations.

- QMS Improvement & Digitalization: Progress on standardization and digitization; reduction in manual errors and process variability.

- Documentation Integrity: Zero critical documentation/data integrity observations.

- Product Quality: Reduction in customer complaints and deviations; batch rejection below agreed thresholds.

- Training & Development: % employees trained vs plan; measurable competency improvement.

- Cross-functional Governance: SLA adherence between QA and other departments; timely escalation resolution.

Key Interfaces / Internal Stakeholders:

- Production / Operations.

- Regulatory Affairs.

- Quality Control.

- R&D / Technology Transfer / Validation.

- EHS / Supply Chain / Engineering.

Key Authorities:

- Approval of SOPs, change controls, deviations & CAPA plans.

- Batch release clearance recommendation from Corporate QA perspective.

- Authority to stop production or shipment in case of critical non-compliance.