GM/Sr GM -Site Quality Head

Job Title: Site Head - Quality

Location: Guwahati

Reports to: CQA Head

Job Summary:

The Site Head of Quality will be responsible for overseeing all quality assurance and Quality

control activities at Guwahati manufacturing site. This role involves ensuring compliance

with regulatory standards, leading quality initiatives, and fostering a culture of continuous

improvement. The Site Head will collaborate closely with cross-functional teams to uphold

the highest quality standards throughout the production process.

Key Responsibilities:

1. Quality Management Systems:

• Develop, implement, and maintain the Quality Management System (QMS) in

accordance with regulatory requirements and industry standards.

2. Regulatory Compliance:

• Ensure compliance with FDA, EMA, and other relevant regulatory agencies.

Lead regulatory inspections and audits, responding to findings with

appropriate corrective actions.

3. Quality Assurance Leadership:

• Lead and mentor the quality assurance team, fostering a culture of

accountability, excellence, and continuous improvement.

4. Audit Management:

• Oversee internal and external audits, ensuring that audit findings are addressed

promptly and effectively. Develop and implement action plans as necessary.

5. Change Control Management:

• Manage the change control process, ensuring that all changes are assessed for

impact on product quality and compliance.

6. Deviation and CAPA Management:

• Oversee the investigation of deviations, ensuring timely resolution and

implementation of corrective and preventive actions (CAPA).

7. Training and Development:

• Develop and implement training programs for staff to ensure understanding of

quality standards and compliance requirements.

8. Collaboration with Cross-Functional Teams:

• Work closely with production, engineering, and supply chain teams to

integrate quality into all processes and facilitate problem-solving.

9. Quality Metrics and Reporting:

• Establish and monitor quality metrics to assess the effectiveness of quality

programs. Provide regular reports to senior management on quality

performance.

10. Continuous Improvement:

• Drive initiatives to enhance product quality, operational efficiency, and

regulatory compliance through Lean and Six Sigma methodologies.

Qualifications:

• Education: Bachelors degree in Life Sciences, Pharmacy, or a related field;

advanced degree preferred.

• Experience: Minimum of 15 to 20 years of experience in quality assurance and

quality control within the pharmaceutical, with 10 years in a leadership role.

• Knowledge: In-depth knowledge of GMP, GLP, and regulatory requirements relevant

to the pharmaceutical industry.

• Skills: Strong leadership, communication, and interpersonal skills; ability to influence

and drive change across teams.

• Analytical Skills: Strong analytical and problem-solving abilities; proficiency in

quality metrics and data analysis.

Preferred Qualifications:

• Certification in Quality Assurance/ Quality Control (e.g., ASQ Certified Quality

Auditor) is a plus.

• Experience with Quality Management Systems software.

What We Offer:

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and advancement.
• A supportive and innovative work environment.