Leading Quality Assurance Specialist for Large Molecule Manufacturing

1 week ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Director of Quality Assurance in Large Molecule Manufacturing

We are seeking a highly skilled Director of Quality Assurance to support our technical team in the biologics drug substance and drug product manufacturing area. The successful candidate will be responsible for ensuring that all quality assurance processes and compliance requirements are met during technical transfers to and from external partners and throughout the continuous commercial manufacturing process at partner sites.

Key Responsibilities:
  • Quality Oversight: Provide general direction on quality goals and objectives, ensuring oversight of all quality-related issues at partner sites.
  • Regulatory Compliance: Ensure that all quality assurance activities comply with regulatory requirements (FDA, EMA, etc.) and internal quality standards throughout the product lifecycle, including during facility start-up and technical transfers.
  • Manufacturing Support: Provide ongoing quality support to partners by resolving quality issues, performing proactive analysis of process performance, and developing plans to ensure compliance and quality meet capacity needs.
  • Collaboration: Work collaboratively with Biologics Quality Operations and other relevant teams within the organization to support the product lifecycle and address quality-related matters.
  • Validation Strategies: Support and oversee validation strategies for new and existing products, ensuring compliance with best practices in quality assurance.
  • Troubleshooting: Troubleshoot quality-related manufacturing issues and support investigations using scientific problem-solving methodologies.
  • Efficiency Improvement: Work with Operations, Quality, and partners to develop more efficient methods to meet regulatory requirements while ensuring quality standards are upheld.
  • Quality Management System: Ensure adherence to the highest quality, compliance, and safety standards by participating in and complying with our Manufacturing Division Quality Management System requirements.
  • Partner Engagement: Collaborate with partners to achieve business goals while fostering a common culture that prioritizes quality and compliance for both organizations.

Requirements:

  • Experience in quality assurance and regulatory compliance in large molecule manufacturing.
  • Strong knowledge of FDA and EMA regulations.
  • Excellent leadership and communication skills.
  • Able to work independently and as part of a team.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a dynamic team in a fast-paced environment.
  • Ongoing training and professional development opportunities.

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