Quality Control Lead（Small Molecule）

Work Location: Wuxi jiangsu China

Responsibilities:

1. Provide Strategic and Operational Leadership for Small Molecule QC team:

• Lead and oversee all Small Molecule Quality Control activities supporting clinical and commercial manufacturing within an ADC CDMO environment, ensuring compliance with global regulatory requirements and business objectives.
• Direct a large QC organization of approximately 100–200 employees, including managers, senior managers, and technical leaders across analytical testing, stability programs, sample management, laboratory compliance, and lifecycle management.
• Establish organizational strategy, operating models, performance metrics, and resource planning to ensure high-quality and efficient laboratory operations.
• Drive continuous improvement, operational excellence, and Lean initiatives to enhance productivity, reduce cycle times, optimize costs, and improve right-first-time performance.

2. Quality, Compliance and Regulatory Leadership

• Ensure QC operations consistently meet cGMP requirements and global regulatory standards, including FDA, EMA, NMPA, PMDA, ICH and other applicable regulations.
• Partner closely with Quality Assurance to maintain a robust quality system and strong quality culture throughout the organization.
• Provide executive oversight for OOS, OOT, deviations, CAPAs, laboratory investigations, change controls and risk assessments.
• Lead inspection readiness programs and serve as a key representative during client audits, regulatory inspections, and due diligence activities.
• Drive data integrity, laboratory compliance, and continuous improvement initiatives across QC operations.

3. Technical and Scientific Leadership

• Provide scientific leadership for analytical method transfer, qualification, validation, verification, and lifecycle management supporting API, intermediates, linkers, payloads, and commercial products.
• Serve as the senior technical authority for chromatography, spectroscopy, mass spectrometry, and other analytical technologies.
• Guide complex technical investigations, troubleshooting activities, and strategic decisions related to analytical challenges.
• Ensure robust analytical support for technology transfer, process validation, PPQ campaigns, stability studies, comparability assessments, and product lifecycle management.

4. Act as a senior client-facing leader and strategic partner for clients, by providing effective communication and playing a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs.

• 5. Build, lead, and develop a high-performing QC organization through effective succession planning, talent development, mentoring, and employee engagement.

Requirements

1.Education:

• Ph.D. or Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or other relevant scientific disciplines.
• Advanced scientific training with strong analytical and pharmaceutical development knowledge preferred.

2.Experience

• Minimum 15–20 years of progressive experience within the pharmaceutical, biotechnology, CDMO, or ADC industry.
• Minimum 10 years of leadership experience managing GMP Quality Control organizations.
• Demonstrated experience supporting both clinical and commercial manufacturing programs.
• Significant experience leading large organizations (100+ employees), including multiple layers of management.
• Experience supporting global regulatory inspections, client audits, and commercial product launches.
• Experience within ADC, highly potent compounds, oncology products, small molecule APIs, or related pharmaceutical manufacturing environments is highly preferred.

3.Technical Expertise

• Deep expertise in analytical testing and characterization of small molecule APIs and drug products.
• Strong knowledge of analytical technologies including HPLC, UPLC, GC, LC-MS/MS, GC-MS, NMR, UV, IR, dissolution, and other characterization techniques.
• Extensive experience in analytical method development, transfer, qualification, validation, and lifecycle management.
• Strong understanding of stability programs, specification management, reference standards, and analytical control strategies.

4.Quality and Compliance

• Comprehensive knowledge of global GMP regulations, ICH guidelines, FDA, EMA, NMPA, PMDA, and other international regulatory requirements.
• Strong understanding of quality systems including deviations, CAPA, change control, risk management, data integrity, and laboratory compliance.
• Demonstrated ability to establish and maintain inspection-ready operations.
• Previous partnership with QA organizations and experience driving quality culture and compliance excellence strongly preferred.

5.Leadership and Business Competencies

• Proven ability to lead through organizational growth, transformation, and change management.
• Strong strategic thinking, problem-solving, and decision-making capabilities.
• Excellent communication and stakeholder management skills, with experience interacting with executive leadership, global clients, and health authorities.
• Strong financial acumen, resource planning, and budget management experience.
• Fluency in English required; experience working in a global matrix organization preferred.

Why Join Us

It is an opportunity to be part of one of the fastest-growing sectors in the pharmaceutical industry, expand your leadership scope, and shape the future of ADC quality management.

1. Accelerate Your Career Through a New Growth Curve

For experienced small molecule quality leaders, this role offers a unique opportunity to expand beyond traditional small molecules into the rapidly growing ADC field. While leveraging your existing expertise, you will gain exposure to Payload, conjugation technologies, and biologics-related operations, broadening your technical and leadership capabilities.

2. Gain Global Business and Quality Exposure

This position supports global clients and international programs rather than a single region or business unit. You will work across diverse projects and customer portfolios, contributing to global quality initiatives and strengthening your international leadership perspective.

3. Be Part of a Strategic and High-Impact Business

Payload is widely recognized as one of the most critical and technically demanding components within the ADC value chain. Joining XDC means becoming part of a highly strategic business platform where you can help build capabilities and shape the future, rather than simply maintaining established operations.

4. Grow with a Fast-Expanding Organization

As a rapidly growing company, XDC offers greater opportunities to drive change, influence business outcomes, and lead organizational development. This is an ideal environment for ambitious leaders seeking broader responsibilities and meaningful impact.

5. Work on a Strong and Expanding Project Portfolio

With a growing customer base and a robust project pipeline, XDC provides long-term career stability and continuous development opportunities. You will play a key role in supporting innovative programs and gain end-to-end exposure across the product lifecycle, from development through commercialization.

Shape the Future of ADC Quality Management

At XDC, you will have the opportunity to combine deep quality expertise with global exposure, contribute to a strategically important business, and build the next chapter of your career in one of the industry's most exciting growth areas.