Quality Assurance Manager Chc Asia

**Title**:
Quality Assurance Manager CHC Asia

**Company**:
Ipsen Pharma Singapore PTE. LTD.

Responsible for the management and oversight of the Quality Management System applied to CHC Vietnam Operations and maintain Quality Control for commercial operations, activities and programs across Asia alliance management, excluding China.

This newly established position aims to establish a strong quality assurance and control over the commercial operations, instill the culture of continuous improvement, and maintenance of local licenses to commercialize our brands, including activities that meet internal and external requirements (WHO; local regulations and relevant Good x Practices), policies and procedures.

**Main responsibilities**:
**Quality Assurance**
- Serve as the primary Quality assurance/system representative and interface for the region.
- Establish Quality Management System (QMS) and quality assurance activities and programs to ensure processes are in compliant with prevailing GxP requirements of HQ and country regulatory framework.
- Foster quality culture by encouraging best practices and a high performing “quality beyond compliance” mindset, both from procedural and patient/customer-centricity perspectives.
- Contribute strongly to building quality and compliance through governance and education.
- Develop, implement, and monitor standard operating procedures (SOPs) to serve business needs in accordance with current laws, corporate standard and policy.
- Ensure a comprehensive GxP training program is rolled out for all employees and partners, including continuous education to ensure sustainable awareness.
- Execute and/or host audit inspection processes in the distributor across GxP functions.
- Determine, evaluate and investigate product quality complaints with appropriate data collection, root-cause analysis, CAPAs, and remediation plan. Where needed, escalate critical quality concerns to Global Quality Commercial Operations and QSEB; collaborate with QSEB to determine CAPAs and execute follow-up with affected stakeholders, including communication documents for customers
- Where necessary, collaborate with QSEB to manage, implement and monitor product recall activities.
- Implement and manage applicable commercial operations Change Control activities.
- Manage and support local analytical product release activities (analytical transfers; protocol and report reviews; facilitate troubleshooting processes; support any OOS; batch release), if applicable.
- In conjunction with local distributor(s), provide oversight of the reception, warehousing and distribution of the Ipsen products, if applicable.
- Ensure that Distributors comply with Good Distribution Practices (GDP), including cold chain and transportation processes, when applicable.
- Implement Supplier management policy/procedures specifically on GxP Suppliers/Service providers/Vendors, including approval of subcontracted activities affecting GDP, when applicable.
- Integrate global/regional quality needs and priorities and representing the region at the Ipsen Global Quality Forum.
- Keep current on all important regulatory environment, publications, international regulations, guidelines and requirements, identify shortcomings and initiate working groups to implement changes following the gap analyses, in line with global processes.
- Conduct and/or host risk assessments, self-inspections, regulatory inspections, audits, mock-recalls and should the situation arise, to act as Affiliate Product Recall Lead.

**Collaboration with other Departments**
- Proactively advocate, develop, and monitor quality processes across functions.
- Proactively identify areas for process improvement and facilitate cooperation cross-functionally in the implementation of the QMS.
- Add value by providing stakeholders with quality leadership and operational input towards strategic and tactical activities.
- Strengthen the risk management culture and update the Ipsen Risk Register.

**Communication**
- Develop and maintain a positive and ethical interactions with relevant authorities and distributors.

**Your profile**:
Education / Certifications:

- Ideal: Degree or equivalent work experience in scientific or health related field.
- Minimum: Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences).

**Experience**:

- At least 5 years of experience in a similar position in a multinational pharmaceutical company.
- Proven experience and leadership within Quality operations of multi-national biopharmaceutical.
- Extensive understanding of GxP, Quality Systems and Pharmaceutical responsibilities, with experience in leading quality assurance locally/on site.
- Business savvy.
- Worked in a matrix organization and interfacing with lead/management team.
- Agility to deliver quality work while demonstrating maturity in workload/time management.
- Computer literacy skills.
- Strong organizational abilities.
- Ability to balance between detail orient