Job Description：
The Head of R&D Quality will establish, scale, manage the quality compliance framework four biologics development tech transfer workflows. This role ensures that all client-facing projects—including cell line development, upstream/downstream process development, analytical method development, pilot-scale batches comply with phase-appropriate guidelines. As a key partner to our clients, this leader balances technical agility with regulatory compliance to ensure smooth transitions clinical commercial manufacturing.
Job Responsibilities：
1、Client-Facing Quality Excellence: Act as the primary quality liaison during client audits technical consultations; ensure client quality agreements (QAs) are accurately integrated early-stage R&D process development workflows.
2、Tech Transfer & Scale-Up Quality: Partner closely with Process Development (PD) Tech Transfer (TT) teams to oversee the risk-managed scale-up of customer biologics pipelines (e.g., monoclonal antibodies, recombinant proteins) from lab bench to bioreactscales.
3、Phase-Appropriate QMS: Manage continuously improve a phase-appropriate Quality Management System (QMS) optimized fa CDMO environment, that supports rapid R&D innovation facilitating quick turnaround times fdevelopment milestones while protecting data integrity ensuring absolute compliance.
4、Analytical Method Development Qualification: Oversee quality review approval fthe development, qualified execution, transfer of biological assays, analytical testing methods, stability protocols.
5、Data Integrity & GxP Compliance: Oversee data integrity policies ensure robustness in non-clinical GLP translational studies.
6、Investigations & Root Cause Analysis: Champion phase-appropriate investigation frameworks, leading root cause analysis (RCA) corrective actions (CAPA)
7、Culture of Quality: Cultivate a proactive, collaborative culture of Quality among scientists engineering teams, serving as a strategic partner rather than a bureaucratic bottleneck.
Job Requirements ：
1、Education: Bachelor’s, Master’s, Ph.D. in Bioengineering, Chemical Engineering, Biochemistry, Molecular Biology, a related bioprocess discipline.
2、Experience: 8+ years of progressive quality technical operations experience in a biologics setting, with at least 3+ years within a CDMO service provider business model. Strong record of leading teams.
3、Bioprocessing Expertise: Deep familiarity with biologics development platforms, including mammalian/microbial cell culture, single-use bioreactors, chromatography columns, ultrafiltration/diafiltration (UF/DF), analytical characterization.
4、Regulatory & Industry Knowledge: Thorough understanding of global regulatory frameworks governing biologics production, including cGMP (21 CFR 210/211), ICH Q8 (Quality by Design), ICH Q11 (Development Manufacture of Drug Substances), phase-appropriate requirements fPhase I/II clinical trials.
5、Customer Focus: Supericommunication, negotiation, conflict-resolution skills tailored fmanaging diverse client profiles, from small virtual biotechs to large pharmaceuticalganizations.
6、Technical Proficiency: Experience with biologics development platforms (e.g., cell cultures, bioreactors, chromatography, formulation) computerized system validation (CSV) under GAMP 5.
7、Leadership Skills: Exceptional ability to translate complex regulatory requirements practical, agile R&D laboratory workflows.
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