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The Position
Primary Job Summary
In order to enable Roche’s expanding in Shanghai with growing Drug Product operations, the role of Engineering Quality Manager for a new greenfield project for the large molecule DP facility assumes below primary purposes:
- As an integral part of the project team, this position report to Engineering Quality Head, fully participating and dedicated in project work streams, ensuring proper execution of design/qualification/validation strategies in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations, as well as providing support and guidance for quality processes and procedures during the project phase.
- Ensure that all aspects of CSV, Data Integrity and validation activities and all deliverables of the project, including but not limited to facilities, critical utilities, equipment, laboratory instruments and computerized systems, automation and digital systems, are executed on time and meet compliance requirements.
- Work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved global/local procedure documents, current Good Manufacturing Practices ， and CN/EU Annex-1 across the project during detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.
Technical and Functional Responsivities
- Ensure the project is performed according to the Roche Standards and Good Practices, ensure the site validation program complies with all regulatory and Roche corporate requirement, and Good Practices,
- Responsible for the project CSV, Data Integrity, C&Q strategy execution in Roche compliant to Annex 1, GAMP 5 and applicable regulations in Dragon project phase in collaboration with Project, F&E, MSAT, Manufacturing and C&Q team,
- Oversee as Quality the Strategy and Execution of C&Q, and represent Quality Assurance in design reviews, construction, and qualification activities. Review commissioning and qualification documentation, including URS, IQ， OQ, and PQ protocols/report.
- Support the development and implementation of C&Q and validation plans aligned with project timelines.
- Participate in risk assessments to define qualification/validation requirements. Perform QA reviews of system impact assessments and equipment categorization.
- Act as the QA point of contact for discrepancy, deviation, CAPAs, and change controls related to C&Q activities.
- Provide recommendations for process improvements in C&Q and validation activities.
- Collaborate with project, F&E, MSAT, manufacturing, and QC teams to address quality issues.
Qualification and Experience
Education/Qualifications
- Science Bachelor degree or above.
- Pharmaceutical, Chemistry, Biochemistry, Analysis, Mechanical, Automation or relevant disciplines.
Leadership Competencies
- Self-driven and able to set own targets
- Leading by example. Ability to manage multiple work-streams, create and work within internal timelines, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Strong leadership, teamwork and management skills. Accept feedback from a variety of sources and constructively manages conflict.
Job Required Competencies
- 10 or more years’ work experience in Bio-pharma or related industry, 5 or more years’ people management or project management experience. MNC pharma preferred.
- Aseptic Filling experience is required and Experience in new DP facility project is expected.
- In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE).
- Strong understanding of risk-based approaches to commissioning and qualification/validation. Hand-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ, and cleaning/process validation.
- Fluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization and network.
- Previous experience working in a large matrix-managed environment is preferred.
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.