Head of Quality Systems and Compliance at F. Hoffmann-La Roche Ltd - Poland

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

29 Mar, 26

Salary

0.0

Posted On

29 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, GMP Compliance, Risk Management, Documentation Control, Training Development, Change Management, Regulatory Inspections, Audit Management, Project Management, Stakeholder Management, Problem Solving, Critical Thinking, Communication Skills, Team Leadership, Continuous Improvement, Aseptic Filling

Industry

Biotechnology Research

Description

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 Quality and Technical perspective: QMS management and oversight System Maintenance: Develop, rollout, and maintain a robust QMS framework. Ensure full alignment with Roche’s global standards and local GMP regulations. Change Management: Oversee the Technical Change Control process. Act as the Chair of the Local Change Review Board, ensuring changes are evaluated effectively and implemented without compromising product quality or compliance. Risk Management: Drive the Quality Risk Management program. Provide expertise and tools to ensure potential product and patient risks are systematically assessed, controlled, reviewed, and documented. Documentation: Manage the lifecycle of GMP documentation, ensuring data integrity and compliance with document control standards. Training: Develop and deliver GMP and QMS training programs (including Site Quality Awareness). Ensure relevant employees are adequately trained, and evaluate the effectiveness of training to enhance organizational competence. Complaints & Recalls: Manage the product complaint handling process, ensuring timely investigation and root cause analysis. Oversee the Product Recall system, including leading actual recalls and conducting periodic mock recalls to ensure the organization's readiness and effectiveness in emergency situations. DML Licensing & MAHD management DML Licensing: Lead the application, renewal, and maintenance of DML. Ensure all submissions are timely and accurate to maintain business continuity. MSHD: Manage responsibilities related to the MAH Domestic Agent for imported drugs, ensuring compliance with NMPA requirements regarding local representation and vigilance. Inspection & Audit Management Inspection overall governance: Provide strategic direction and execution for Regulatory Inspections (NMPA, Provincial/City FDA) and Group HQ Audits. Audit Operations: Act as the primary moderator during inspections, prepare daily summaries, and lead the timely preparation of responses to observations (CAPA). Self-Inspection: Establish and oversee the Site Self-Inspection Program to drive continuous improvement of the site’s systems, processes, and operational performance. Site Quality Governance & Management Quality Council:Organize and facilitate Quality Committee/Council meetings. Present quality compliance status, data analysis, metrics, and risk overviews to the management team to drive decision-making. Produce monthly reports to regional management teams highlighting successes and hot spots. Site Master File Management (SMF): Manage SMF and related site management documentation to ensure they reflect the current operational state. Support the mobilisation of new sites or facilities from a quality and compliance perspective Aspire Project Leadership Quality Readiness Lead: Serve as the designated Aspire Project Quality Readiness Lead. Ensure all quality-related business activities and milestones within the Aspire project are delivered on time and meet the required quality standards. Other Lead and support defined projects, improvements or solutions across the required scope of Roche PT. Support the compliance, regulatory and training activities as required and any other responsibilities as assigned by Quality Head, Biologics Manage and control QS&C budget planning, forecast and execution, including OpEx, Capex and continuous improvement projects. Leadership perspective: 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. Education/Qualifications The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. In-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities. Experience on managing regulatory inspections with Global Health Authorities and of interacting with representing the company to Health Authorities, their agents, or related entities. 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. Aseptic Filling experience is required and experience in new DP facility project is expected. 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 project management skills, 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 100’000 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Head of Quality Systems and Compliance will oversee the development and maintenance of a robust Quality Management System (QMS) and ensure compliance with global standards and local regulations. This role includes managing risk assessments, documentation, training programs, and leading regulatory inspections.