Subnetwork Lead Operations Partnering Instruments

• Responsible for Instrument product release process and document management process in Roche Suzhou.
• Ensure that the process is complies with the requirements of European, US, China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.

• Perform activities as required to meet Q&R goals and objectives independently and leads through the performance of these activities. Able to identify improvements and implement with collaboration from supervisor. Participate in cross functional Global initiatives. Leads and/or participate in large/global cross-functional or cross-chapter projects. Acts as a coach for colleagues with less experience and helps them develop skills/expertise. Navigates in complex situations by applying a diverse skillset.
• Prepare documentation for and participate in audits as applicable.
• Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
• Complete all required training in learning solution.
• Responsible for training, coaching, mentoring and leading other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met. Has a deep product and process understanding and is able to translate this understanding into tangible learnings for other employees. Act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in We@RocheDiagnostics. Model behaviors to support the organization’s transformation to new, more Agile Ways of Working – e.g. new decision making/governance practices, collaboration, etc.
• Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance.
• Ability to work day to day without supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently with cost, culture and compliance. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and presents both issues and solutions to supervisor.
• Develop and Lead process improvements to meet business needs taking into consideration cost, compliance and complexity to implement robust processes. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovations across the global organization.

• Know and follow the We@Roche Diagnostics Dimensions and Roche Core Competencies. Adopts and adheres to the Leadership Commitments. Accountable for meeting commitments. Is flexible able to shift priorities while balancing commitments and daily work requirements, independently. Seeks candid feedback on his or her performance and acts on it. Recognizes the contributions of teammates and peers. Establishes strong collaborative relationships inter-departmentally, across sites and across all of the global organizations and leverages these connections to achieve our key results. Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.
• Co-create and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long term goals. Negotiate with Senior Leadership across the organization to influence decision making. Lead, coach, and guide the organization. Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth in accordance to Servant-Leadership principles. Build a strong pipeline of talent and robust succession plans for key positions.
• Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes. Be the champion and advocate for Engrained Quality at the Site. Build a culture of continuous improvement and model lean leadership principles. Ensure your organization proactively seeks out and consider the voice of the customer in defining their priorities and outputs

• We employ talented people and expect great things from them. Contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. Build and develop your capabilities to contribute more to the team, local and global organization, customers and patients. Apply new ways of enhancing your work to drive approaches that increase productivity, reduce costs or mitigate significant compliance issues within your area of influence as well as across sites and all of the global functions. Works as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. Push the boundaries to enable, develop and drive smart, risk-based compliant processes that result in quick and efficient innovation.

• Instrument Product Release and documentation management

• Business Process Owner for batch record review process, ensure all relevant interfaces with operation, QC within RDSZ and interface with corresponding QA organization outside of RDSZ is well integrated from both process and SAP perspective.
• Perform Instrument Product Release tasks following defined business process.
• Provide product release related KPI trending in timely manner.
• Representative from RDSZ QA in Instrument product release and document management area in global network, including develop/setup interface corresponding interface process with other QMSs.

• Support internal and external audit and timely provision of batch record requested by inspectors.
• Get involved in internal audit as auditor.

• Initial training, leading and development of directly subordinated employees as per “Performance Management” and “Succession and Talent Management” procedures in regards to functional requirements and skills. Conduction one-on-one, assessment of training needs, salary adjustments, review of tasks as well as assignments and reassessment of further training needs with respect to skills, products, processes and regulatory requirements. Collaboration in improvement projects which aim to optimize documentation functions in agreement with specifically affected functions.

• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
• Master degree of Biology or Engineer will be preferred.
• Competent with routine application of MS Office
• At least three (3) years of demonstrated people leadership experience or equivalent experience. Experience in directing and leading large successful organizations. Demonstrated experience and knowledge of Quality operations and processes.At least five (5) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience.
• Detailed understanding of Medical Device Instrument product manufacturing will be preferred
• Well experienced in MD Instrument product development and process validation (3-5 years), have deep understanding of product FMEA and risk assessment philosophy will be preferred
• Well experienced in the field of development and implementation of QM / QA processes
• Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards. Demonstrated experience in European, US and other relevant Health Authority inspections.
• Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, CFDA. Experienced with the principles and system processes / tools within the QA/QM field.
• Proficient language skills (written and spoken) in Chinese and English Competent with routine application of MS Office, SAP and other common office software.
• Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations.
• Independent working style, well-experienced in organizational structures.
• Proficient in communicating and presenting topics with business clientele.
• Experienced in analysis of QA/QM processes, particularly with respect to compliance, efficiency and effectiveness.
• Demonstrated ability to adequately interpret and implement quality standards considered
• Experienced in dealing with all level of authorities including China FDA officers, TUV auditors, Korea FDA officers, etc.
• Knowledgeable in statistics.
• Professional QM-auditor with specific certification / degree.

Roche