Head - Quality & Regulatory - Pharma

- Establish and maintain a robust quality management system (QMS) that complies with relevant standards and regulations (e.g., ISO 13485, FDA, WHOPQ 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 non-conformance incidents, to drive continuous improvement.

- Conduct regular internal audits and coordinate external audits by regulatory bodies or certification agencies.

- 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 cross-functional teams to ensure compliance with labeling requirements, post-market surveillance, adverse event reporting, and other regulatory obligations.

- 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.

- Establish supplier evaluation and qualification processes to ensure that all purchased components and raw materials meet quality standards.

- Conduct periodic audits and assessments of suppliers to monitor their compliance with quality and regulatory requirements.

- Foster strong relationships with suppliers, promoting collaboration and continuous improvement to enhance overall supply chain quality.

- Define and monitor customer satisfaction metrics, such as product performance feedback, complaint resolution, and on-time delivery.

- Implement processes to capture and address customer feedback, including complaint handling, investigation, and corrective/preventive actions.

- Collaborate with customer support and sales teams to ensure that customer expectations are met, and regulatory obligations related to customer interactions are fulfilled