Head - Quality & Regulatory - Diagnostic Manufacturing/IVD Industry

2 weeks ago

Mumbai, Maharashtra, India P R GLOLINKS CONSULTING PRIVATE LIMITED Full time
What we are looking for

  • Candidate should be around 15 years of experience in Manufacturing industry with USFDA/WHO approved Company in Quality Function.
  • Experience in Diagnostic Manufacturing Company will be an added advantage.
  • Expertise and Experience in handling multiple products and sites.
  • Effective Man Management skills.
  • Indepth knowledge of regulations of the concerned markets.
  • Candidate should be good in handling documentation & all other Quality Compliances.

Key Responsibility Quality Management:

  • Establish and maintain a robust quality management system (QMS) that complies with relevant standards and regulations (e.g., ISO 13485, FDA, WHO-PQ regulations).
  • Implement effective quality control processes throughout the manufacturing cycle, including raw material inspection, production monitoring, and final product release.
  • Define and track key quality metrics, such as product defect rates, customer complaints, and nonconformance incidents, to drive continuous improvement.
  • Conduct regular internal audits and coordinate external audits by regulatory bodies or certification agencies.

Regulatory Compliance :

  • Stay updated on the latest regulatory requirements and standards relevant to IVD testing kits in the countries/regions where your products are marketed.
  • Ensure timely submission of regulatory filings and documentation for new product registrations, variations, and renewals, in collaboration with regulatory affairs teams.
  • Establish processes for regulatory monitoring, tracking changes in regulations, and assessing the impact on product compliance.
  • Work closely with crossfunctional teams to ensure compliance with labeling requirements, postmarket surveillance, adverse event reporting, and other regulatory obligations.

Product Development and Lifecycle Management:

  • Collaborate with R&D and product development teams to ensure that quality and regulatory considerations are integrated into the design and development of new IVD testing kits.
  • Conduct risk assessments and implement risk management strategies throughout the product lifecycle.
  • Oversee the validation and verification processes for new products or changes to existing products, ensuring adherence to applicable standards.
  • Develop and maintain technical documentation, such as product specifications, manufacturing instructions, and product change control records.
In addition he will be responsible for

  • Supplier Quality Management
  • Customer Satisfaction
  • Continuous Improvement
)

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