Job summary
Job post source
This job is directly from Syngene International Limited
Job overview
The Lead-Quality Assurance role at Syngene International Limited oversees QA functions at a large molecule manufacturing plant, ensuring regulatory compliance and quality standards.
Responsibilities and impact
The Lead is responsible for QA activities including qualification and validation of facilities and equipment, document review and approval, training on QMS procedures, coordinating cross-functional QA activities, and ensuring compliance with biologics manufacturing standards.
Experience and skills
Requires 10-15 years in Quality Assurance within biologics or pharmaceutical manufacturing, deep regulatory knowledge (USDA, USFDA, ICH, EU, Health Canada), audit experience, strong technical expertise in biologics, leadership, and training skills.
Work environment and culture
Syngene values safety highly, fosters a culture of quality, compliance, accountability, and collaboration in a fast-paced regulatory environment.
Company information
Syngene International Ltd., founded in 1993, is a global discovery, development, and manufacturing organization serving pharmaceutical and biotech industries with a strong team of 4240 scientists and notable clients worldwide.
Team overview
The Lead reports to the Head of Quality and works closely with cross-functional teams including Manufacturing, Regulatory Affairs, and Supply Chain within the Quality department.
Job location and travel
The position is located in Baltimore, Maryland, United States.
Unique job features
The role involves leading QA strategy for biologics manufacturing at a large molecule site, interfacing with regulatory authorities, and ensuring inspection readiness, distinguishing it as a senior leadership position in QA.
Company overview
Syngene International Limited is a leading contract research, development, and manufacturing organization based in India, serving global pharmaceutical, biotechnology, and agrochemical companies. The company generates revenue by providing integrated discovery, development, and manufacturing services across small molecules, biologics, and specialty chemicals, supporting clients from early-stage research to commercial supply. Established in 1993 as a subsidiary of Biocon Limited, Syngene has grown through strategic partnerships with major clients like Bristol Myers Squibb and Amgen, and operates state-of-the-art research facilities in Bengaluru. Its reputation for scientific innovation, regulatory compliance, and scalable solutions has positioned it as a trusted partner for multinational corporations seeking to accelerate product development. Candidates should be aware of Syngene’s commitment to quality, safety, and sustainability, as well as its significant role in advancing global healthcare and life sciences.
How to land this job
Position your resume to highlight your extensive experience in Quality Assurance within biologics or pharmaceutical manufacturing, emphasizing leadership in large molecule environments and regulatory compliance.
Focus on showcasing your expertise in managing QA functions such as qualification, validation, documentation, and regulatory inspections, aligning with Syngene's requirements for operational oversight and compliance.
Apply through multiple channels including Syngene International Limited's corporate careers page, LinkedIn, and relevant job boards to maximize your application visibility.
Connect with current Syngene employees in the Quality Assurance or Biologics divisions on LinkedIn; start conversations by referencing recent company news, asking about the QA culture, or inquiring about key challenges the QA team faces.
Optimize your resume for ATS by incorporating keywords from the job description such as 'Quality Management Systems', 'validation', 'regulatory compliance', 'biologics manufacturing', 'USFDA', and 'cross-functional leadership' to pass initial screenings effectively.
Use Jennie Johnson's Power Apply feature to automate tailoring your resume, identify the best application platforms, and find LinkedIn contacts, allowing you to focus more on preparing for interviews and networking.
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