Senior Quality Manager

2 weeks ago

Beach Rd, Singapore INTEGRITY PARTNERS PTE. LTD. Full time

10 years exp

**Roles & Responsibilities**

My Client, a reputable global pharmaceutical company is looking out for a Senior Quality Manager to support their regional distribution Center.

**Job responsibilities**:

- Manage/perform quality operations/activities for Company’s Asia RDC operations and ensure its compliance to applicable regulatory and requirements to support continuous operations of Company’s Asia RDC and continuous provision of quality compliant products.
- Management of all relevant regulatory and/or certification inspections/audits for Company’s Asia RDC to ensure successful maintenance/renewal of licenses/certifications.
- Provide quality input/support timely for relevant business projects, initiatives and requests, new product introduction, product launches, product variation if needed.
- Provide support to other Asia QA members or Asia countries quality operations if needed.
- Manage QA operation budget for Company’s Asia RDC.
- Ensures that all product specifications and related documentation are in alignment with current registered details.
- Maintains and updates QA SOPs and tracks/maintains training records
- Assume QMR role for Company’s RDC (bottle labelling/secondary packaging, redressing, warehousing, and distribution) and prepare the facility for GMP inspection and certifications by local and various other countries' health authority, host and prepare/complete CAPA for inspection findings and close inspection.

**Requirements/Skills**:

- Possess a graduate degree in life sciences discipline with 10 years’ experience in Pharmaceutical and/or Medical Device Company in quality function. At least 8 years’ GMP and facility quality operation experience and knowledge is needed to support the set up the appropriate QMS
- Experience in GMP (packaging or manufacturing), Audit, QA Batch Release/Management, experience in Regional Distribution Centre (RDC) QA operations, Complaints management, CAPA/RCA (Root Cause Analysis) management
- Knowledge of regulatory standards related to PICs/GMP (manufacturing/packaging), ICH, RDC, ISO 13485, cold change management
- Able to work independently with vendor management and with stakeholders in Asia region and escalate issues as needed
- Good stakeholder management with leadership skills and accountability
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to manage complex projects and timelines in a matrix team environment.
- Excellent verbal and writing skills and fluent in English and as applicable, local language is desired
- Flexibility to travel up to 20%.

**How to Apply**

Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502

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