Head QA

Job Title:

Head of Quality Assurance – Vaccine Drug Substance Manufacturing Plant

Location: Lalru - Punjab

Reports To: Quality Head – Vaccine (VDSP &VDPP)

Job Summary:

The Head of Quality Assurance (QA) will oversee the Quality Assurance function to ensure the manufacturing processes and products meet stringent regulatory standards for vaccine drug substance production. This role is critical in maintaining the integrity of the vaccine production process by ensuring compliance with GMP (Good Manufacturing Practices), regulatory requirements, and quality control standards. The individual will work closely with the production, R&D, and regulatory teams to ensure that all operations align with the highest quality and safety standards.

Key Responsibilities:

1. Quality Culture: Creating and Building overall Quality Culture, behaviour and thinking in the plant for patient safety, taking feedback especially around failure from executors with a positive mind-set, learning from failure as a team, encouraging team to share openly failures, finding solutions together as a team. Assuring the team regularly that reporting failure is not punished but hiding failure, false reporting, data fudging, data manipulation, is punished.
2. Recording what is done, doing what is recorded, speaking what is done and recorded is quality.
3. Ensure Science based decision making.
4. Quality Management System (QMS):

Develop, implement, and continuously improve the QMS to ensure it meets international regulatory standards (e.g., USFDA, WHO, MHRA, TGA and other Stringent Regulatory Agencies)

• Lead the Quality Assurance team in maintaining certifications such as GMP, ISO, and other applicable standards.
• Ensure timely audits and inspections (internal, regulatory, and third-party) are conducted and findings are addressed promptly.

1. Regulatory Compliance:

• Ensure that the manufacturing processes for vaccine drug substances comply with local and international regulatory guidelines.
• Stay updated with global regulations related to vaccine manufacturing and drive their implementation within the organization.
• Oversee the preparation and submission of regulatory filings and respond to regulatory queries and inspections.

1. Regulatory and Customers Inspections: Coordinating and Participation in external regulatory inspections, customer audits and monitoring CAPAs with all the sites until completion including their effectiveness.
2. Technology Transfer:

• Guiding plant QA on Technology Transfer matters for manufacturing process and analytical methods.

1. Quality Control and Assurance:

• Oversee the quality control process, including in-process testing, final release testing, and stability testing.
• Ensure the integrity and traceability of raw materials, intermediates, and finished products through proper documentation and compliance with batch release processes.
• Establish and monitor key quality metrics (KPIs) and implement corrective and preventive actions (CAPA) as needed.

1. Team Leadership and Development:

• Lead, mentor, and develop the QA team to ensure a high level of competence and motivation.
• Collaborate with other departments (Manufacturing, R&D, and Regulatory Affairs) to ensure an integrated approach to quality management.
• Drive a culture of quality across the organization, encouraging proactive problem-solving and continuous improvement.

1. Risk Management:

• Conduct risk assessments to identify potential quality risks in the production process and implement strategies to mitigate them.
• Oversee deviation management, non-conformance investigations, and root cause analyses.
• Ensure timely implementation of CAPAs following deviations or audit findings.

1. Documentation and Record Keeping:

• Oversee the management of all QA documentation, including SOPs, batch records, deviation reports, and audit findings.
• Ensure timely and accurate documentation as per GMP requirements, including e-documentation where applicable.

1. Vendor and Supplier Quality Management:

• Manage the quality of materials supplied by vendors, including raw materials, equipment, and other supplies.
• Conduct audits of suppliers and ensure adherence to quality standards throughout the supply chain.

1. Continuous Improvement:

• Lead initiatives aimed at improving product quality and manufacturing efficiency.
• Promote a culture of continuous improvement within the QA department through process optimization, staff development, and technology adoption.

1. Budget Management:

• Manage the QA department’s budget and ensure resources are allocated efficiently to maintain the highest quality standards.

Qualification:

• Master’s degree or higher in Chemistry, Biotechnology, Microbiology, Pharmaceutical Sciences, or a related field.

Experience:

Minimum of 10-15 years of experience in Quality Assurance within pharmaceutical or biotech industries, with at least 5 years in vaccine or biologics manufacturing.

• Regulatory Knowledge: Deep understanding of regulatory frameworks, including GMP, USFDA and WHO guidelines for vaccine production.
• Leadership Skills: Proven experience in leading QA teams, managing cross-functional projects, and driving quality culture in a complex manufacturing environment.
• Communication: Strong written and verbal communication skills, with the ability to effectively interact with regulatory agencies, senior management, and external partners.

Key Competencies:

• Expertise in regulatory compliance and quality standards for vaccine manufacturing.
• Strong leadership and team development skills.
• Excellent problem-solving and decision-making abilities.
• Proficiency in risk assessment and CAPA processes.
• Ability to manage complex projects and multitask in a fast-paced environment.

Interested candidate may directly share their resume to Mr. Kulvinder Sarao, CHRO & Sr. Vice President at his email id kulvindersarao@panaceabiotec.com and /or sandeepsingh@panaceabiotec.com