Quality Head | Biological E | Hyderabad

Job Description

Roles and Responsibilities

• Primary responsibilities include leading and executing overall administration in Quality Assurance, Quality Control & Development QA for the Vaccines Division.
• Knowledge in overall Quality including validations, batch review and disposition, document management, audits, deviations, change controls, product complaints, oversight on production and QC activities, and GMP Training along with good communication and analytical skills required.

Demographics & Scope of Role:

• This role will be based out of Hyderabad with Supervisor responsibility with a few immediate direct reports.

Reporting & Relationship:

• This role will report to the COO of the Vaccine Division

Key Result Areas and Expected Outcomes:

Goals and Deliverables are as follows:

• Provide leadership to the organization as a key advisor and decision-maker. Take responsibility and ownership to steer the company in the right direction. Actively participate in meetings, and speak your mind.
• Ensure that GMP facilities are adequately designed for the production of clinical and commercial products. Manage Four manufacturing sites for drug substances and drug products.
• To ensure technology transfer from Research & Development to Production.
• Escalate and communicate significant quality issues to senior management periodically. Chair the MRB meetings.
• Ensure that manufacturing and testing operations are performed in compliance with cGMP requirements and within turnaround time, so the product can be released to the market as committed.
• Ensure GMP utilities/facilities, equipment, processes, cleaning, and analytical methods are validated as per the established validation program.
• Establish and continuously improve a robust and scalable QMS system (change control, deviation, CAPA, product complaints, etc.). Always be aware of the key risks to the organization (process, systems, facility, labs, etc.) and have a mitigation plan.
• Ensure supplier management program is established and followed that includes supplier qualification and audits.
• Self-inspections are conducted as per the schedule and corrective actions are identified and completed.
• Head Recall committee and Recall any batch of product from the market if required.
• Review of GMP documents, review and approval of Policy Documents. Author new policies
• Ensure Technical (Commercial Supply) and Quality agreements are in place as applicable with corporate partners and third parties and vendors.
• Manage external audits by partners and all regulatory inspections. Draft responses and comply with CAPAs as committed.
• Oversight of Quality control laboratories under BE’s quality systems and GXP.
• Oversight of critical investigations pertinent to Market complaints. Lead complex investigations where necessary.
• Oversight of Quality budgets, and staying within the budget expense.
• Motivate the team, Ensure performance management reviews are conducted on time and is effective.
• Interact with external stakeholders – DCGI, WHO, Gates Foundation, CEPI, DCVMN, corporate partners such as GSK, Janssen, etc.
• Any other task assigned by the supervisor.

Desired Competencies:

• Candidate must have a good understanding of QA and QC operations related to the Vaccines/Biologics/Biosimilar Industry.
• Strong interpersonal skills to interact with and manage external stakeholders (WHO, DCGI, etc). Need to gain the respect and recognition, as a ‘key contact fo the organization’ and ultimate decision maker for Quality and Compliance for the organization
• Enable raising the bar on compliance and building stronger teams, and quality systems strengthening. Always question non-value-added activities. Headcount budgeting must be very
• Proven team player skills in building teams that deliver results and resolution.
• Must be well versed with Schedule M, CDSCO guidelines, WHO & ICH guidelines. Knowledge of USFDA and EU guidelines would be helpful.
• Positive attitude and Proactive; with the ability to propose calculated risks and display adaptive behavior
• Strong decision-making that takes into account Quality, Compliance, and Business needs.
• Should be familiar with the fundamentals of vaccine development, licensure, and commercialization. Ability to lead cross-functional teams in “crisis situations” and “Navigate the Narrows”.
• Excellent analytical and negotiation skills

Knowledge Skills & Equivalent Experience:

Post-Graduation / Doctorate in Life Sciences stream with relevant 25+ years of experience in Vaccines/Biologics/Biosimilar Industry.