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

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Quality and Technical Guidance

• Provide leadership and technical support for all GMP/quality activities for manufacturing and other assigned areas of responsibility.

• Engage in proactive measures to promote a Quality culture while ensuring all applicable GxP compliance requirements are fulfilled in alignment with corporate policy and local legal requirements.

• Lead the QA team to oversee all QA programs and projects and guide teams to ensure cross-functional integration coordination and alignment according to regulatory corporate and division requirements.

• Lead and mentor the team in professional knowledge continuously enhancing their technical capabilities.

• Contributes by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.

• Manage and control QA budget planning forecast and execution including OpEx Capex and continuous improvement projects.

• Support the compliance regulatory and training activities as required and any other responsibilities as assigned by Quality Head Biologics .

• Facilitate and support Head of Quality for monitoring and continuous improvement for relevant key performance indicators of RCPT Quality department.

Quality Management System (QMS) Implementation:

• Develop implement and maintain a comprehensive QMS for all site operations. This includes creating and managing standard operating procedures (SOPs) policies and quality metrics tailored for a new biologic aseptic filling site.

• Direct the review and approval of all applicable Quality assurance documents and ensure documents are updated.

Batch Record Review & Release:

• Oversee local aseptic filling & packaging product batch release process provide QA oversight on materials management and ensure materials released on-time.

• Lead the review and approval of all batch records ensuring they are complete accurate and compliant with cGMP standards before final product release.

GMP Compliance Oversight:

Maintain open communication with stakeholders and other relevant with above-site functions and not limited to MKG MM MSAT F&E and internal Quality functions. Act as the primary authority on GMP compliance for all site activities.

This includes:

• Manufacturing: Overseeing the aseptic filling process to ensure it adheres to approved procedures.

• Analytical Testing: Verifying the quality of all in-process and finished product testing.

• Material Management: Ensuring the quality of incoming raw materials and components.

• Facility & Utilities: Managing the qualification validation and ongoing maintenance of the facility and its utilities.

Provide regular reports on quality assurance activities and progress to leadership.

Quality Event Management: Lead the sites quality event management processes including:

• Change Control: Conducting quality assessments for all proposed changes to processes equipment and materials.

• Deviation Management: Overseeing investigations and ensuring timely resolution of all deviations. Review and approve deviation/exception/ investigation reports.

• CAPA Follow-up: Ensuring all Corrective and Preventive Actions (CAPA) are effectively implemented and verified.

• Market Recall: Developing and managing a robust process for any potential market recalls.

Audits and Inspections:

• Represents the QMS system owner during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

• Prepare the site for and act as the primary contact during internal external and regulatory inspections (e.g. FDA EMA).

Additional tasks relevant to Greenfield project

• Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.

• Involve and support planned events related to local packaging products including imported DS & segmented filling local packaging.

Leadership

• Be an active and visible change agent and promote a flexible and open attitude towards new opportunities.

• Create an environment with strong team spirit timely and effective communication sense of urgency and high motivation and inspire teams to achieve short-term and long-term goals.

• As a senior leader to drive networking activities cross-functional collaborations and decision making.

• Drive and define strategies priorities and compliance standards across the areas of accountability.

• Develop a competent team through coaching mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.

• Take proactive measures to promote a positive safety culture and ensure all applicable safety health and environmental requirements are met in accordance with company policies and local legal requirements.

• Embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture throughout the organization by encouraging experimentation and learning.

Qualification and Experience 能力与经验

Education/Qualifications

• The candidate should have at least a Degree in pharmaceutical sciences life sciences biology biotechnology chemistry chemical engineering or a related discipline.

• Certification and trainings such as auditor training or QP training will be advantageous.

Leadership Competencies

• Take a genuine interest in people Listen carefully tell the truth and explain the why Empower and trust people to make decisions.

• Discover and develop the potential in people Strive for excellence and extraordinary results Set priorities and simplify work Congratulate people for a job well done

Job Required Competencies

• A minimum experience of 10 years with 5 years of supervisory position in the pharmaceutical or biotechnology in quality assurance GMP compliance operations or validation ideally in a multinational company.

• FDA/EU cGMP know-how and a thorough understanding of ICH guidelines together with exposure to the international regulatory network.

• Experience with tools like SAP Veeva Orca and demonstrating strong stakeholder management independent problem-solving critical thinking abilities and agile skills with flexibility to adapt to changes.

• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.

• Good decision-making capability ability to drive and facilitate daily work projects processes and initiatives efficiently while being detail-oriented well-organized and managing time effectively to multitask prioritize and handle problems and escalations.

• Experienced in new facility startup readiness and operation ramp up including organization people and operation management system.

• Fluent communications skills in English and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

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.