Ozone Pharmaceuticals - Head - Corporate Quality Assurance

Description:

Key Responsibilities:

Quality Assurance Leadership:

- Lead and oversee the Corporate Quality Assurance function across multiple manufacturing facilities.

- Develop and implement organization-wide quality strategies, policies, and quality management systems.

- Ensure compliance with global regulatory standards including USFDA, MHRA, EU GMP, WHO, TGA, and other international regulatory requirements.

- Drive a strong quality culture across the organization with focus on compliance, operational excellence, and continuous improvement.

Regulatory Compliance & Audits:

- Handle regulatory inspections and customer audits from global regulatory authorities.

- Ensure audit readiness across all manufacturing sites and functions.

- Review audit observations, CAPA effectiveness, deviation management, and compliance closure activities.

- Provide strategic direction for remediation plans and compliance enhancement initiatives.

Quality Systems Management:

- Oversee implementation and monitoring of Quality Management Systems (QMS).

- Ensure effective management of deviations, change controls, investigations, OOS/OOT, CAPA, complaints, and risk assessments.

- Review and approve SOPs, protocols, reports, specifications, validation documents, and quality-related procedures.

- Ensure adherence to data integrity and documentation compliance standards.

Validation & Process Excellence:

- Monitor validation activities including process validation, cleaning validation, equipment qualification, and computerized system validation.

- Drive process improvement and operational excellence initiatives across manufacturing and quality functions.

- Identify quality gaps and implement preventive and corrective measures.

Stakeholder & Team Management:

- Collaborate closely with Manufacturing, QC, Regulatory Affairs, R&D, Engineering, Supply Chain, and Plant Leadership teams.

- Mentor and lead large quality teams across multiple locations.

- Build strong relationships with customers, regulatory bodies, and external stakeholders.

- Provide leadership in quality-related decision-making and risk management.

Metrics, Governance & Reporting:

- Monitor quality KPIs, compliance metrics, and organizational quality performance.

- Present quality updates, compliance status, and risk assessments to senior leadership and management committees.

- Ensure timely escalation and resolution of critical quality and compliance issues.

Required Skills & Qualifications:

- Bachelors or Masters degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or related discipline.

- 15-22 years of experience in Quality Assurance within Pharmaceutical or regulated manufacturing industries.

- Strong exposure to Corporate QA, Plant QA, and global regulatory compliance.

- Experience handling USFDA, MHRA, EU, WHO, and other international audits.

- Strong knowledge of GMP, GLP, Data Integrity, Validation, and Quality Systems.

- Proven leadership experience in managing multi-site quality operations.

- Excellent communication, stakeholder management, and team leadership skills.

- Strong analytical and problem-solving abilities.

Preferred Skills:

- Exposure to sterile / injectable / OSD / API manufacturing environments.

- Experience in digital quality transformation and automation initiatives.

- Knowledge of risk-based quality management approaches.

- Certification in Quality Management Systems or Six Sigma is an added advantage