At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

1. Primary Purpose of Job

• Scientific operations and management:

o As a member of CICoR Pharmaceutical Sciences (PS) leadership team responsible for PS and Early Development (ED) departmental operational activities including vendor/CRO management operation-related financial planning capital expenditures (Capex) and event management

o Consolidate PS scientific and non-scientific operational strategies aligning with CICoR Head of PS and PS scientific

o Primary communication channel to internal and external stakeholders/collaborators

• Compliance & quality leadership:

o Lead GxP and clinical compliance for PS/ED in China/APAC by aligning standards and practices with global quality leads and stakeholders

• Process improvement & stakeholder engagement:

o Drive efficient consistent and compliant processes for vendor relationships and CRO oversight

o Responsible for centralized oversight of departmental operational activities and processes such as material management capex management event management compliance management and communication management etc.

o Act as the primary communication channel for internal and external stakeholders

• Scientific Operation function management:

o Manage the matrix scientific operations team providing guidance and performance control

o Point of Contract for communication and alignment with pRED PS Scientific Operations and relevant Chapter Leads

2. Principle Roles & Responsibilities / Accountabilities

• CRO & vendor management

o Develop and manage operational relationships with CROs in China/APAC including ongoing communication issue resolution and organizing meetings/visits.

oPerform regular market landscaping of the China/APAC CRO landscape to identify new partners and industry trends contribute to CRO/vendor selections

oProvide comprehensive oversight of assigned vendors managing the scope volume and overall spending of outsourced activities.

• Quality compliance & governance

oEnsure robust CRO governance by coordinating all governance meetings (e.g. regular review) tracking action items and managing CRO inspections and visits.

oLiaise with global GxP & Quality Excellence to apply and maintain global quality standards within CICoR PS.

oMaintain and ensure adherence to the Quality Management System (QMS) for all CICoR PS activities.

oEnsure all Health Authority (HA)-related questions or issues are adequately addressed and resolved.

• Process optimization & cross-functional collaboration

oDevelop implement and regularly revise optimized operational processes outsourcing documentation and related guidelines (e.g. SOPs White Papers).

oEstablish and maintain strong interfaces with key internal partners including global Enabling Sciences and other global/local PS & ED functions.

oProcurement Finance P&C and Site Operations within CICoR and the broader Roche Shanghai organization (e.g. PD Biosample Operations DTAs).

• Operational Execution

oEnsure meticulous documentation and tracking of all issues to facilitate clear communication follow-up and timely resolution.

oSupport the development implementation and regularly revision of optimized/harmonized operational practices/processes incl. the related outsourcing process documentation

3. Qualification and Experience 能力与经验

• University education in Scientific field (Human or Veterinary Medicine Chemistry Biology etc.) or Business.

• A minimum of 10 years of professional experience within the pharmaceutical industry.

• Solid understanding of outsourcing procurement and business management principles.

• Working knowledge of local and global GxP regulations with a specific focus on GCP and GLP.

• Proficient in business support solutions (e.g. databases MS Excel PowerPoint Spotfire).

• Demonstrated skills in communication collaboration and stakeholder management.

• Strong negotiation and influencing abilities.

• Basic familiarity with relevant Chinese and other countries regulations especially US and EU.

• A proven team player with a collaborative approach.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.