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Experienced Manager – Clinical Process and Quality Manager responsible for overseeing clinical quality systems, process compliance, audit readiness, and operational excellence within clinical research and healthcare environments. Skilled in clinical process management, quality assurance, regulatory compliance, SOP governance, and risk mitigation. Adept at collaborating with cross-functional clinical teams to ensure adherence to GCP guidelines, regulatory standards, and quality requirements while driving continuous process improvements and operational efficiency.
Roles & Responsibilities
- Lead clinical process and quality management activities across clinical operations.
- Ensure compliance with GCP, regulatory guidelines, SOPs, and quality standards.
- Develop, implement, and maintain clinical quality management systems and procedures.
- Conduct quality reviews, process audits, and compliance assessments for clinical studies.
- Monitor deviations, CAPA, risk assessments, and quality metrics to ensure operational effectiveness.
- Collaborate with clinical operations, data management, pharmacovigilance, and regulatory teams.
- Support inspection readiness and coordinate responses to audit observations and regulatory findings.
- Review clinical documentation, study records, and trial processes for compliance accuracy.
- Identify process gaps and implement continuous improvement initiatives across clinical functions.
- Provide quality oversight during study startup, conduct, and closeout activities.
- Ensure proper training and adherence to clinical procedures and quality standards.
- Monitor vendor and CRO compliance with contractual and regulatory requirements.
- Prepare quality reports, dashboards, and management review presentations.
- Support implementation of process automation and quality enhancement initiatives.
- Mentor and guide team members on clinical quality practices, compliance expectations, and process improvements.
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About Sun Pharma
Sun Pharmaceutical Industries is one of the world’s leading specialty generic pharmaceutical companies. Founded in 1983, the company provides high-quality and affordable medicines to patients in more than 100 countries. With a strong global presence, Sun Pharma focuses on innovation, healthcare accessibility, and patient care.
The company has grown into the No.1 pharmaceutical company in India and continues to expand across international markets through advanced research, modern manufacturing facilities, and a diversified product portfolio.
Quick Facts
- Founded: 1983
- Global Revenue: US$ 6.2 Billion
- Employees: 43,000+ worldwide
- Manufacturing Facilities: 41
- Countries Served: 100+
- India Ranking: No.1 Pharmaceutical Company
Vision
“Reaching People and Touching Lives Globally as a Leading Provider of Valued Medicines.”
Sun Pharma aims to improve healthcare access by delivering trusted medicines and innovative healthcare solutions worldwide.
What Sun Pharma Does
Sun Pharma manufactures and markets a wide range of pharmaceutical products, including:
- Generic medicines
- Specialty medicines
- Branded generics
- OTC (Over-the-Counter) products
- Active Pharmaceutical Ingredients (API)
- Complex and innovative drug formulations
The company develops medicines across several therapeutic areas such as:
- Cardiology
- Dermatology
- Oncology
- Neurology
- Gastroenterology
- Respiratory care
- Diabetology
- Ophthalmology
- Urology
Innovation & Research
Sun Pharma is known for its strong focus on research and development (R&D). The company invests approximately 6–8% of its annual global revenue into innovation and product development.
R&D Highlights
- 2,900+ R&D professionals
- Advanced formulation and analytical development
- Expertise in complex products like:
- Inhalers
- Liposomal drugs
- Nasal sprays
- Controlled-release medicines
- Lyophilized injections
Global Presence
Sun Pharma has established a strong footprint across:
- India
- United States
- Brazil
- Mexico
- Russia
- South Africa
- Canada
- Australia
- Japan
- Europe
The company is also among the leading specialty generic companies in the U.S. market.
Employees & Work Culture
Employee Strength
Sun Pharma employs more than 43,000 people globally from diverse cultural and professional backgrounds. The company believes in empowering employees, encouraging innovation, and supporting personal and professional growth.
Employee Promise – “Create Your Own Sunshine”
Sun Pharma encourages employees to take initiative, learn continuously, and grow together. The company’s employee culture is built on three pillars:
Better Everyday
- Continuous learning and improvement
- Skill development opportunities
- Performance-driven environment
Take Charge
- Leadership opportunities
- Employee empowerment
- Ownership and accountability
Thrive Together
- Team collaboration
- Diversity and inclusion
- Respect and mutual support
Company Culture – Sunology
Sun Pharma follows a workplace philosophy called Sunology, which represents the company’s values and way of life.
Core Values
- Humility
- Integrity
- Passion
- Innovation
- Quality
- Reliability
- Trust
- Consistency
These values help create a positive, ethical, and growth-oriented work environment for employees across the globe.
Code of Conduct
Sun Pharma follows a strong global code of conduct to maintain:
- Ethical business practices
- Transparency
- Employee responsibility
- Patient-focused healthcare standards
- Compliance with international regulations
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