Head QC

JOB DESCRIPTION
 

Job Title: Head - Quality Control
Job Location: Mangalore
Job Level: Experienced

About Syngene: Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose: Provide strategic leadership and oversight of the Quality Control (QC) function to ensure robust analytical operations, regulatory compliance, data integrity, and continuous improvement for small molecules APIs including tides. The role is accountable for delivering high-quality analytical outputs, maintaining audit readiness, and fostering a culture of safety, quality, and operational excellence.

Job Responsibilities

1. Strategic Leadership & Governance

• Lead the QC function with accountability for end-to-end analytical operations, compliance, and performance.
• Define and implement QC strategy aligned with organizational quality objectives and regulatory expectations.
• Establish strong governance for quality systems, data integrity, and compliance oversight.
• Act as the primary escalation point for all QC-related risks, compliance issues, and critical decisions.

2. Regulatory Compliance & Quality Systems

• Ensure compliance with cGMP, GLP, GDP, Data Integrity, and global regulatory requirements (USFDA, EMA, MHRA, PMDA, etc.).
• Provide strategic direction for handling QMS events including deviations, OOS, OOT, LIR, and product quality complaints.
• Ensure robust investigation practices, timely closure, and CAPA effectiveness.
• Drive proactive identification of gaps and implementation of best-in-class compliance practices.

3. Laboratory Operations Excellence

• Oversee all QC laboratory activities including raw material, intermediate, API, stability, in-process, and cleaning sample testing.
• Ensure on-time batch release and analytical deliverables without compromising compliance.
• Maintain laboratory operations in a continuous Audit-Ready (ATAR) state.
• Drive initiatives to improve productivity, Right First-Time (RFT) performance, and reduction in laboratory errors.

4. Technical & Scientific Leadership

• Serve as technical authority in analytical sciences, microbiology, environmental monitoring, and method lifecycle management.
• Review and approve critical documents including VMP, URS, validation protocols/reports, specifications, SOPs, COAs, and trend reports.
• Ensure alignment with latest regulatory expectations and pharmacopeial updates.

5. Equipment, Infrastructure & Resource Management

• Ensure robust systems for instrument calibration, qualification, and preventive maintenance.
• Oversee qualification of facilities, utilities, and analytical equipment.
• Ensure availability of manpower, materials, reagents, and infrastructure.
• Support new product introductions and regulatory changes effectively.

6. Audit & Inspection Leadership

• Lead QC readiness for regulatory, client, and internal audits.
• Ensure timely audit responses, closure of observations, and CAPA effectiveness verification.
• Represent QC during regulatory inspections and client interactions.

7. Data Integrity & Compliance Oversight

• Ensure adherence to Data Integrity principles (ALCOA+).
• Drive awareness, training, and monitoring programs.
• Establish systems to prevent, detect, and remediate data integrity risks.

8. People Leadership & Capability Development

• Build and lead a high-performance QC team.
• Ensure training, qualification, and completion of mandatory programs.
• Provide coaching on GMP, investigations, and technical competencies.
• Foster a culture of accountability, ownership, and continuous improvement.

9. Cross-Functional & Client Collaboration

• Collaborate with Manufacturing, QA, Regulatory, and other cross-functional teams.
• Ensure timely material release and project deliverables.
• Maintain strong client communication and stakeholder engagement.

10. Continuous Improvement & Innovation

• Lead initiatives to enhance laboratory efficiency, productivity, compliance robustness, and digitalization.
• Drive decisions using trend analysis and performance metrics.
• Promote adoption of best practices and new technologies.

11. Financial & Business Management

• Manage QC budget and cost optimization initiatives.
• Ensure efficient resource utilization and productivity improvements.
• Prepare MIS reports, dashboards, and management updates.

12. Documentation & Review Oversight

• Review and approve analytical records, COAs, change controls, deviations, and validation documents.
• Ensure documentation compliance with regulatory and audit requirements.

13. EHS & Safety Culture

• Drive a strong “Safety First” culture.
• Ensure compliance with EHS policies and regulatory requirements.
• Monitor safety metrics and implement risk mitigation strategies.
• Ensure accountability towards zero incident goals.

Educational Qualification:  M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree.

Technical/functional Skills:

• Good communication skills and experience in small molecules API (Including tides) industry.
• Regulatory and compliance expertise

Behavioural Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Strategic leadership & decision-making
• Stakeholder and client management
• Continuous improvement mindset

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.