Senior Quality Operations Manager
3 days ago
We are seeking a highly skilled Senior Quality Operations Manager to join our team at SL-Human Resource Consultancy Pte Ltd. The ideal candidate will have extensive experience in quality assurance, with a strong background in managing quality operations in the Asia region.
About the RoleThis is an exciting opportunity to lead operational quality assurance activities in Asia for the importation, secondary assembly/repackaging, storage, and distribution of our products.
Main Responsibilities:- Representing the Asia QA Team as QA Lead and Quality Management Representative in responsible countries.
- Leading operational quality assurance activities in Asia, including importation, repackaging, release, storage, and distribution of pharmaceutical and medical devices products.
- Developing, executing, and maintaining our Quality Management System (QMS).
- Oversight of Contract Manufacturers/Suppliers (CMOs) and ensuring compliance to GxP standards.
- Planning, performing, and ensuring successful closures of internal and external audits.
- Providing post-market support and resolving quality issues promptly.
- Driving the continuous supply of quality compliance products.
- Providing quality improvement inputs and support to new product introduction/product launches.
- A minimum of 5-7 years of quality assurance experience in the pharmaceutical and/or medical devices industry.
- Experience in both manufacturing environment and commercial quality.
- Knowledge and application of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), ICH, ISO 9001, ISO 13485, and PIC/S.
- Proven stakeholder management experience (e.g., distributors, regulatory authorities).
- Audit and inspection experience (e.g., internal, regulatory authority, CMO, supplier).
The estimated salary for this role is SGD $120,000 - $180,000 per annum, depending on qualifications and experience.
Why Join Us?At SL-Human Resource Consultancy Pte Ltd, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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