Head of HGRAC and Operation Excellence

HGRAC and Operation Excellence Senior Manager lead internal HGRAC management and clinical operation excellence to support high efficiency HGRAC and clinical operation activities and accelerate the trial execution in China.

HGRAC Affairs.

Serve as Amgen business process owner (BPO) for Amgen’s HGRAC Management Process (from initial application compilation through to study closure and data release). As Amgen HGRAC BPO, work closely with Amgen GDO organizations,  QCA (Quality, Compliance & Audit) and identified BPOs to develop and maintain Amgen HGRAC SOPs/Work Instructions ..

Serve as Amgen China SME for all HGRAC-related activities, working with various local and global cross-functional stakeholders and respective study team to ensure the HGRAC applications are conducted in a timely and compliant manner. Perform Amgen internal review of HGRAC applications prior to submission.

Lead/project manage and /or participate to provide input on relevant Amgen tasks force teams to enhancement awareness of HGRAC process and activities, provide process improvement for both China and global.

Provide oversight on HGRAC submissions across China study portfolio, lead timely communication of status and issues effectively to Amgen HGRAC governance committee. Perform Amgen internal review of HGRAC annual self-check report prior to submission.

Set up and monitor key performance metrics on HGRAC-related activities and HGRAC compliance. Work as key role together with QCA for HGRAC-related inspections. Develop CAPAs to address any performance and compliance gaps identified, in collaboration with QCA function. Coordinate HGRAC quality improvement initiatives in collaboration with QCA function.

Develop insight to build Amgen internal expertise and knowledge of HGRAC. Be responsible for interpretation of HGRAC regulations and implementation guidelines following consultation with HGRAC officers as internal expert.  Also provide support in Amgen collaborated projects with partners as internal expert.

Develop and build relationships with HGRAC officers, serve as Amgen primary POC with HGRAC. Identify external opportunity for Amgen engagement in HGRAC related external activities.

Develop and deliver training on an ongoing basis to key stakeholders involved in the HGRAC process.

Clinical Operation Excellence.

Lead/ project manager to design, execute and install innovation initiatives into local process to enable operation excellence for China simultaneous drug development. Projects are cross functional in nature and require integrated approach to define, pilot and implement.

Manage China clinical operation process through closely collaboration with GSO, CPO, QCA and identified BPOs regional and global from end to end to ensure operational effectiveness upon business needs and local regulation requirements.

Understand global and regional initiative, external regulation changes, evaluate the impact on China clinical operations and take the lead of local implementation where appropriate. Also development capability within China clinical operation to implement new technology or system from operational wise.

Act as the liaison from China clinical development to proceed new supplier sourcing process that meet clinical operation deliverables, including but not limited to identify, evaluate, qualify and frame structure for implementation and oversight.

Involve in and contribute to external industry operation excellence activities as per business needs.

Performance management of local staff as per business needs.

Key Competencies

Effective leadership skills

Ability to work in cross-functional teams and exhibit strong collaboration skills

Ability to manage team(s) to accomplish increasingly complex, specific projects.

Ability to influence and motivate others outside of direct line of authority.

Ability to interface effectively with all levels.

Ability to navigate through a complex team or matrix environment.

Effective meeting management.

Quick learner, proactive, takes initiative.

Skilled in understanding highly ambiguous situations.

Results oriented and goal driven.

Strong oral and written communication skills.

Ability to organize, interpret communicate and present information effectively.

Strong problem-solving skills.

Able to develop creative output based on interpretation and analysis.

Excellent organization and planning skills with an attention to detail.

Ability to work independently.

Demonstrates willingness to put an extra effort when necessary to pursue tasks to conclusion.

Preferred Qualifications

BA/BS/BSc in life science or relevant.

Minimum 8 years of  experience within Pharmaceutical/CRO industry, with  prior clinical operations /drug development experience; minimum 2 years of HGRAC submissions related experience

Excellent written and oral communication skills in both English and Mandarin.

Knowledge

Advanced knowledge of clinical trials management including regulations, guidelines, and clinical trial processes esp. in China.

Extensive knowledge of ICH/GCP regulations and guidelines and HGRAC Regulations