Quality Manager EM CHC China

• Location: Shanghai China

• 20% Remote working, 80% in the office and 20% of travel expected 

• Job type: Full time/ Fixed Term

The Quality Manager EM CHC China shall manage thExperience

e quality and compliance oversight of Contract Manufacturing Organisations (CMOs), third-party manufacturers and suppliers within the EM CHC CHINA entity according to the GxP requirements, international, and Company global quality requirements.

The QUALITY MANAGER, EM CHC CHINA shall serve as the functional quality representative and ensure that CMOs / third party /suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are in compliance with international and local regulatory requirements, MAH License, quality agreement, the registered dossier, and Company global quality documents when applicable.

The QUALITY MANAGER, EM CHC CHINA shall ensure regular monitoring, assessment of records and results related to the contracted GMP activities. The QUALITY MANAGER, EM CHC CHINA shall contribute to business operation by establishing partnerships and establishing trust with the CMOs / third party /supplier business partners and providing quality oversight and support for quality operations activities. The QUALITY MANAGER, EM CHC CHINA shall escalate activities, issues, progress to Head of Quality, EM CHC AMEA & China.

The QUALITY MANAGER, EM CHC CHINA shall assist in the establishment and continuous development of a robust Quality System of an appropriate standard and shall lead the key areas of Quality Assurance as applicable for the EM CHC CHINA entity in collaboration with the Quality Excellence Manager, EM CHC AMEA & China.

The QUALITY MANAGER, EM CHC CHINA will plan, organise and coordinate their workload in coordination with that of other Quality team members within the EM CHC CHINA hub, so as to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Company procedures. The QUALITY MANAGER, EM CHC CHINA will have responsibility to ensure that their EM CHC CHINA hub meets Quality Key Performance Indicators, in line with Organisational and Regulatory Standards and will take part in Quality and Regulatory Audits if required.

The QUALITY MANAGER, EM CHC CHINA shall support the empowerment of team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence of the Quality Documentation, Quality Systems Management and Quality Technical Support.

The QUALITY MANAGER, EM CHC CHINA will collaborate across the full EM CHC AMEA & China entity to assist and support leadership and Quality workload as required to drive continuous improvement and efficient compliance.

About you 
Experience & knowledge:

At least 8 years working experience in quality or manufacturing in pharmaceutical industry, China MAH experience would be desirable
At least 5 years’ experience within a Quality Leadership or project management role

Core competencies:

Strong Leadership skills including Influencing, mentoring, coaching and motivation of a team
Strong Pro-active, Planning, Organisational, Prioritisation and negotiation skills with a good sense of responsibility
Strong interpersonal and communication skills (writing & verbal)
In depth knowledge of the applicable GMP (China, EU, ICH PIC/S)
Balanced Judgment / Risk based approach
Ability to work in a matrix organization
Ability to work independently and write technical reports
Quality experience and knowledge within a cGxP, pharmaceutical environment
Internal and External Audit experienceAnalytical thinking, Problem solving, hands-on troubleshooting, Risk assessment, and root cause analysis skills