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The Position

Main Purpose of the Position

Provide quality and compliance oversight for assigned external GxP suppliers and outsourced products to ensure compliance with cGMP and Quality Agreement requirements. External GxP suppliers can include CDMOs, CLOs, CROs, CWO, partners, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers.Serve as the Quality Point of Contact (PoC) for designated suppliers and/or products and contribute as a key member of GxP supplier cross-functional management teams to select, implement, manage and decommission these suppliers as applicable to ensure quality of product supply and/or materials or services.Provide quality expertise and compliance assessment for in-licensing and M&A due diligence events, as applicable.As assigned, represent Quality as the Single Point of Contact (Q-SPOC) to the Technical Development Team (TDT) for early stage programs (see Technical Job Roles section below). As assigned, act as a Delegate of the Swiss Responsible Person (see Technical Job Roles section below).

Technical Job Responsibilities

Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage and Decommission), including but not limited to: process or method validations, Roche audits, Health Authority inspections, complex investigations, product complaints, and regulatory submissions, as assigned.Develop, negotiate and maintain Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers, as well as with Partners, Collaborators and External Sponsors as applicable, and ensure compliance with agreements.Collaborate with GxP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and timeliness with the supplier; and escalate as appropriate.As applicable, manage all required activities to support Make Assess Release (MAR) of Roche products including approval of master process documentation, batch documentation review, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance.As applicable, release, reject or quarantine Roche products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Roche requirements, cGMP and the schedule.  Support RP and QP Declaration and Certification requirements as applicable.As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs.As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of compliance.As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches.As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements.     

Functional Job Responsibilities

Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.Approve documents as authorized and described by Roche policies, procedures and job descriptions.Be accountable for behaviors described in Roche Code of Conduct. Deliver business outcomes in support of departmental objectives.Maintain and communicate work priorities to meet goals and timelines.Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable and evaluate systems in place.Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement.Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations.As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required.May mentor and/or coach colleagues within and outside the organization.

Technical Job Roles
As assigned, based on relevant training and qualifications
TDT QSPOC role 
The TDT QSPOC (Quality Single Point of Contact) for Investigational Medicinal Products (IMP):
may mentor and/or coach colleagues within and outside the organization.

Is a strategic matrix leader role in the Technical Development Team (TDT) and responsible for strategic end-to-end product quality oversight until pivotal go.Works cross-functionally for the assigned molecules or products, providing leadership for quality oversight. The TDT QSPOC collaborates with IMP Quality Operations, TDTs, Early Stage Technical Development Committees and the IMPQ Leadership Team to develop and implement a product quality strategy and plan.

Delegate of the Swiss Responsible Person

As applicable, the GxP Supplier Quality Manager is assigned as delegate of the Swiss Responsible Person
a) for commercial products in Switzerland (“Fachtechnisch verantwortliche Person, FvP” as defined in SSD-0208222). 
b) for IMPs in Switzerland (“Fachtechnisch verantwortliche Person, FvP” as defined in SSD-0117038)
 
Within this role, the GxP Supplier Quality Manager

Is reporting directly to the Swiss RP with respect to lot disposition and related questions for a) commercial products as per SSD-0208222 and b) IMPs as per SSD-0117038, as applicableIs responsible for the lot disposition (release or reject) of commercial products (i.e. drug substance or API, bulk drug product, and semi-finished and finished products) or IMPs (i.e. investigational medicinal products e.g., bulk drug product materials, reformulated comparator products, active pharmaceutical ingredients).Ensures that the quality of the a) commercial products produced on behalf of FHLR, Pharma Technical Operations or b) IMPs, manufactured on behalf of Technical Research and Development (TR&D) is in accordance with the current SwissMedic Licenses (refer to CER-0496983). For IMP: documents regulatory restrictions on batch certificates, and performs batch certification for Switzerland and RoW countries.

Firewalled Projects Participant
The incumbent acknowledges that she/he is bound by all confidentiality obligations imposed by her/his Employment Agreement/Proprietary Information Agreement (or in the case of a non-employee, under the contract between Roche and her-/himself or her/his employer, agency, or contract company) in connection with her/his access to Confidential Information, including firewalled projects. Before resuming quality oversight and responsibility for a firewalled project, the incumbent confirms that she/he understands that all contents are Confidential Information and that unauthorized disclosure or use of such Confidential Information may result in termination of her/his employment or services and/or legal action.

Qualifications and Skills

Ideally, a B.A. or B.S. degree in life sciences or equivalent.Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience. Experience with GxP suppliers such as CMO, CLO and direct material suppliers is a plus.Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.Ability to interpret quality standards as they relate to GxP suppliers.Operational Excellence expertise is a plus.Highly competent in MS office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.Ability to communicate clearly and professionally both in writing and verbally.Fluency in oral and written English is a must. Additional language skills are a plus.This position may require up to 10% domestic and/or international travel.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.

Roche is an Equal Opportunity Employer.