Site Quality Head
Job ID: 292178
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience Required: 20+ years in Quality, including minimum 3 years as Site Quality Head
Role Overview
The Site Quality Head is a senior leadership position responsible for directing and elevating quality operations across the manufacturing site. This role ensures that all products consistently meet global quality, safety, and compliance standards. As the principal custodian of Quality Assurance (QA) and Quality Control (QC), the Site Quality Head directly influences regulatory compliance, operational performance, product integrity, and patient safety.
This position plays a strategic role in strengthening quality culture, driving continuous improvement, optimizing manufacturing processes, and ensuring stringent adherence to cGMP and global regulatory expectations. The role also requires strong collaboration with cross-functional teams to support sustainable business growth.
Key Responsibilities
Lead and manage Quality Assurance and Quality Control teams to ensure robust implementation of all quality systems.
Develop, implement, and maintain quality policies aligned with cGMP, FDA, EU, ICH, PIC/S, ISPE, and other relevant regulatory standards.
Oversee quality performance across the manufacturing lifecycle from raw materials to finished product release.
Conduct internal audits, facility inspections, and compliance assessments in line with global regulatory requirements.
Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality issues and drive continuous improvements.
Lead investigations, deviation management, and root cause analyses; implement effective CAPA programs.
Present key quality metrics, performance reports, and compliance updates to leadership teams.
Provide strategic oversight for technology transfer activities, including qualification, validation, change control, and customer communication.
Ensure quality systems remain updated in accordance with evolving regulatory guidance and industry best practices.
Promote a culture of proactive quality, operational excellence, and risk-based decision-making.
Required Skills and Competencies
In-depth understanding of cGMP, quality management systems, and international regulatory expectations.
Strong analytical and problem-solving abilities, with a proactive and structured approach.
Excellent communication, leadership, and cross-functional collaboration skills.
Proven experience managing quality improvement programs and driving compliance excellence.
Expertise in technology transfer, stability studies, qualification and validation, environmental monitoring, cleanroom standards, and AHU systems.
Knowledge of tools such as FMEA, DOE, SQC, and Change Control systems.
Who You Are
Education:
Bachelor of Engineering (Mechanical/Electrical/Chemical/Biotechnology)
OR Master’s in Microbiology
Experience:
Minimum 20 years of experience in Quality functions within the pharmaceutical manufacturing industry
At least 3 years in a Site Quality Head or equivalent leadership role
Experience working with reputable pharmaceutical organizations or multinational companies is preferred
Strong customer focus, decisive mindset, and the ability to lead teams effectively.
Demonstrated capability in managing regulatory inspections and maintaining compliant operations.
What We Offer
You will join a diverse global team driven by curiosity, innovation, and scientific excellence. The organization supports inclusive growth, continuous learning, and opportunities to contribute to impactful advancements in healthcare and life sciences. You will be part of a culture that encourages professional development, ownership, and meaningful contributions to human progress.
Equal Employment Opportunity
The company adheres to all federal, state, and local Equal Employment Opportunity laws. Employment decisions are made without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any legally protected category. Retaliation for good-faith reporting of concerns is strictly prohibited.
Fraudulent Job Offer Notice
Candidates are advised to verify the authenticity of any communication claiming to represent the company. Unauthorized third parties may attempt to share fraudulent job offers. Refer to official channels for accurate recruitment information.
Applicant Profile Update
Applicants who applied before April 16, 2025 can access their previous submissions through the old portal. New applicants must create a fresh profile to track current and future applications.
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