MSAT Qualification Lead

Leadership

• Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers, 

• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.

• Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

• Contribute to a culture of continuous improvement and model lean leadership principles

• Contribute to a culture of transparent, high performance, empowerment and innovation culture.

• Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex qualification workflows, troubleshooting technical challenges, and developing skills in MSAT operations.

 

Technical 

Engineering Project Support and Site Start Up Readiness: 

• Participate in the design and construction of new facilities, including but not limited to URS review, FAT, SAT, IOPQ, tech transfer and other aspects related to MSAT activities, thereby contributing to project delivery.

Technical Expertise & Routine Operation:

• General Customer Service: Identify the customers that are the recipient of the service delivered.  Utilize tools such as CRM/Helpdesk, SPOC to establish this understanding and document accordingly. Develop effective relationships with key customers in order to understand their business and expectations. Deliver services according to established service level agreements. Response to customers is timely and communication is efficient. Seek feedback from customers and/or stakeholders on performance and ability to meet expectations.  Incorporate feedback. Takes accountability to balance customer expectations and value for Roche. Takes ownership for problem resolution and escalates as appropriate.

• Support Other Colleagues within the team: Support other colleagues within the qualification team as required (such as Time-based Requalification).

• Periodic Review Execution: Execute periodic review of GMP equipment, including protocol, and getting approved.

• Qualification triggered by Change: Execute qualification triggered by change accordingly, include protocol, and getting approved.

• CSV Execution: Supervise Testing and Execute Testing in CSV.

• Periodic Assessment: Execute periodic assessment as required.

• Qualification Planning and Report: Execute qualification plan and report, include protocol, and get approved.

• Independently finish qualification activities and solve the relative issue, give guidance to the other engineer in the team.

• Coordinate Qualification Implementation within technical division:

• Provide the technical expertise for routine work and for Site Master Plan projects and Site Engineering projects as well. Actively cooperate with other departments, stakeholder to solve problems effectively

• Prepare, review and approve specific qualification summary sections of regulatory submissions. Present the qualification program to regulatory authorities during routine and pre-approval inspections. Drive internal audit and regulatory observation responses, in addition to self identifying gaps and corrective actions for qualification deficiencies as required.

• Ensure timely and accurate qualification data analysis, review, reporting and trending of data in support of make, test, release and other required metrics.

• Recommend actions to address adverse findings and/or identify cost effective modifications to current processes as applicable.

• Other tasks assigned by the manager.

Qualification and Experience 能力与经验

Education/Qualifications 

• Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above

 

Job Required Competencies 岗位所需胜任力 

• 5 or more years qualification experience, 8 or more years MSAT/Technical or qualification experience in the injection pharmaceutical industry, MNC Bio-pharma preferred

• People management experience is a plus

• Prior experience in validation is advantageous

• Demonstrated experience in strategic thinking, exceptional customer service skills; highly skilled in negotiations, collaboration, and influencing

• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification 

• Strong communications skills including the ability to communicate fluently in English, both verbally and written; holds difficult conversations and works through conflict; checks in with colleagues to ensure comprehension of key points are accurately conveyed

• Strong business acumen, communications, and analytical thinking required

• Strong interpersonal, leadership, collaboration and conflict resolution skills

• Experienced in new facility startup readiness and operation ramp 

• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry

• Experience leading major change initiatives strongly preferred

• Project management skills and Leading team capability preferred

• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working

• Knowledge of Quality management