Vertical Head Quality CTO

Job Summary
This role is for a Head of Quality API Vertical responsible for defining and executing the quality strategy across QA QC functions to ensure alignment with commercial and manufacturing goals regulatory compliance and continuous improvement in API vertical operations.

Roles & Responsibilities
You will be responsible for developing and executing the quality strategy and action plans for API Business Quality aligning them with commercial and manufacturing goals and driving simplification automation and capability building across QA and QC functions.
You will be responsible for reviewing plant QA and QC operations through periodic reports and meetings identifying trends in non-conformances audit findings and complaints and providing guidance for corrective actions and continuous improvement.
You will be responsible for establishing and monitoring systems SOPs and performance metrics for In-Process QA Change Control and quality culture initiatives including rewards consequence management and competency development.
You will be responsible for supporting and guiding QA QC (Development and Commercial) and External Manufacturing teams resolving escalated issues and serving as a backup for QA/QC heads during audits or critical activities.
You will be responsible for building and maintaining quality systems for external partners conducting audits signing off on quality agreements and ensuring compliance with API quality standards through training and communication.
You will be responsible for overseeing internal and external audits acting as audit host for regulatory inspections driving audit response and CAPA closure processes and ensuring all-time audit readiness.
You will be responsible for leading risk management initiatives by identifying quality risks across processes developing mitigation strategies and overseeing investigations and impact assessments of critical discrepancies.
You will be responsible for managing talent development within the quality function including goal setting performance reviews training needs assessment recruitment retention planning and capability building aligned with future business needs.

Qualifications :

Educational qualification: Masters in Pharmacy/Life Sciences/Chemical Engineering is mandatory
 

Minimum work experience: 20 years of experience
 

Skills & attributes &Critical exposures
Functional Skills
Audit Management
Regulatory Inspections 
Supplier Quality Management
Technology transfer

Resident Skills
Product Quality (QA/QC)
Current Good Manufacturing Practices (cGMPS)
Regulatory Compliance
Quality Management Systems (QMS)
Risk Management

Behavioural Skills
Collaboration & Communication Proactively engages cross-functional teams to ensure alignment throughout product documentation and review cycles.

Process Ownership Demonstrates accountability for documentation quality compliance and continuous improvements in MES and PAS-X systems.

Adaptability & Learning Agility Quickly absorbs technical concepts responds to regulatory changes and supports training and integration in evolving manufacturing environments.

Critical exposures
Experience in risk management including Enterprise Risk Management risk assessment programs and crisis management is desired.

Experience in Supply Chain Quality Assurance Contract Manufacturing Quality Management and product quality & compliance oversight including pharmacovigilance is desired.

Exposure to strategic laboratory management CMO operations and planning the global and regional quality roadmap is preferred

Exposure to Quality Transformation Initiatives - Leading large-scale quality transformation programs driving innovation and process excellence is preferred.

Exposure to customer quality requirements and serve as a primary point of contact for customer regarding quality and compliance related issues and enquiries

Additional Information :

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time