Quality Control (QC) Manager

Job Title: Quality Control (QC) Manager

Location: Noida, India
Salary: Competitive, based on experience
Employment Type: Full-Time
Reports To: [Head of Quality, or Senior Management]

About Advancells Group:

Advancells Group is an innovative leader in the field of regenerative medicine, specializing in the manufacturing and marketing of stem cells and exosomes. We are committed to advancing healthcare through cutting-edge research and product development, delivering top-quality regenerative therapies to our clients. As we continue to expand, we are looking for a dedicated and experienced Quality Control (QC) Manager to oversee the quality testing process, ensure compliance with industry standards, and drive continuous improvement in our products and services.

Position Overview:

We are looking for a highly skilled Quality Control Manager with expertise in the testing and quality assurance of stem cells and exosomes before product dispatch. This is a critical mid-to-senior-level role that involves overseeing the QC process, ensuring that all products meet the necessary regulatory standards, and leading efforts for overall product and quality improvements. The QC Manager will also be responsible for establishing relationships with external labs or institutions to perform specific tests not conducted in-house.

Key Responsibilities:

1. Quality Control Management:

• Oversee the quality testing of stem cells and exosomes during various stages of the production process.
• Ensure all tests required for the release of stem cell products meet the Good Manufacturing Practices (GMP) standards and other relevant industry regulations.
• Implement and maintain quality control procedures to test product safety, efficacy, and purity.
• Manage batch release processes ensuring that all testing and documentation are completed before product dispatch.
• Develop and oversee protocols for in-process quality control, including microbial testing, sterility tests, viability assays, purity tests, and cell characterization.
• Monitor and analyze test results, ensuring products meet internal and external quality standards.

2. Coordination with External Labs:

• Identify and establish partnerships with certified external labs and institutions for conducting specialized quality tests (e.g., genetic testing, contamination analysis, detailed characterization).
• Act as the primary liaison between Advancells and external testing labs to ensure efficient and timely testing of products.
• Ensure that external test results meet regulatory standards and integrate findings into the final product quality assessment.

3. Product Improvement:

• Collaborate with cross-functional teams (R&D, production, and marketing) to contribute to product development and improvement initiatives.
• Provide expert input on potential areas for improving product quality and consistency.
• Lead the efforts to continuously enhance the quality assurance process through the introduction of new testing protocols, equipment, and methodologies.

4. Compliance and Documentation:

• Ensure that all QC procedures are in compliance with local and international regulatory standards (e.g., ICH, WHO, ISO).
• Prepare and maintain detailed quality control documentation, including test results, certificates of analysis, and validation records.
• Ensure traceability of all products and tests conducted through robust record-keeping systems.
• Oversee the audit process and participate in regulatory audits to ensure compliance with quality standards.

5. Team Leadership and Training:

• Manage and mentor a team of QC technicians and analysts to ensure high performance and adherence to quality standards.
• Develop and deliver training programs to ensure the QC team is updated on the latest techniques, tools, and regulatory changes.
• Foster a culture of quality awareness and continuous improvement across the company.

6. Customer Satisfaction and Feedback:

• Contribute to the development of customer satisfaction metrics related to product quality.
• Ensure that product quality aligns with customer expectations and regulatory requirements.
• Address customer complaints or issues related to product quality, working closely with the customer support team and R&D to resolve them.

Key Requirements:

Experience:

• Minimum of 5-8 years of experience in Quality Control within the biotech, pharmaceutical, or stem cell industry.
• Previous experience with stem cell manufacturing, exosome production, or similar cell-based therapies is highly desirable.
• Proven track record of managing external testing relationships and collaborating with labs or research institutions.

Skills & Expertise:

• Strong understanding of Good Manufacturing Practices (GMP), GLP, and ISO 9001 standards.
• In-depth knowledge of quality control techniques specific to biological products such as stem cells, including viability testing, microbial contamination testing, endotoxin testing, genetic testing, and more.
• Familiarity with industry regulations such as FDA, EMA, ICH, and other applicable standards for biological product testing.
• Excellent understanding of product release criteria, stability studies, and product characterization.
• Ability to analyze complex scientific data and translate findings into actionable insights for improvement.
• Proficient in using laboratory management software, LIMS systems, and document management tools.

Soft Skills:

• Strong leadership and team management capabilities.
• Excellent problem-solving skills, particularly in quality troubleshooting and root cause analysis.
• Outstanding communication skills with the ability to present and explain complex scientific data to both technical and non-technical stakeholders.
• High attention to detail and a methodical approach to quality assurance.

Education:

• Bachelors or Master’s degree in Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related field.
• Additional certifications in quality control or GMP compliance would be a plus.