WuXi AppTec · 3 hours ago
QC Director
Middletown, DE
Full-time
Onsite
Director/Executive
10+ years expWuXi AppTec is a leading global pharmaceutical and biotechnology organization, and they are seeking an accomplished Quality Control (QC) Director to oversee all QC operations for their new drug product manufacturing site. The QC Director will lead various QC functions, ensure compliance with regulatory standards, and drive continuous improvement in laboratory operations.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Provide strategic leadership for QC Analytical, QC Microbiology, and QC Operations teams, ensuring alignment with corporate and site objectives
Develop and implement QC startup plans, including staffing, training, SOP creation, method transfers, and deployment of quality systems
Oversee laboratory design input, layout optimization, and equipment selection, procurement, installation, and qualification (IQ/OQ/PQ) for analytical, microbiology, and support laboratories
Ensure QC laboratories, workflows, and processes meet cGMP requirements and global regulatory standards (FDA, EMA, ICH, USP, EP, JP)
Coordinate QC support for technology transfers, drug product manufacturing, process validations, cleaning validations, and operational readiness activities
Ensure all QC activities are executed in compliance with cGMP, FDA, EMA, ICH, USP, EP, JP, and other applicable guidelines
Maintain inspection readiness at all times; prepare for and lead client, regulatory, and internal inspections, ensuring timely and effective follow-up on findings
Oversee implementation and maintenance of QC documentation systems, data integrity programs (ALCOA+), and compliance archives
Lead QC participation in internal and external audits, ensuring prompt closure of observations and CAPAs
Manage QC budgets, staffing, and resource allocation to meet project, operational, and client timelines
Oversee execution of batch release testing, stability programs, environmental monitoring, method validations, and method transfers
Lead or approve deviation investigations, root cause analyses, and CAPA implementation for QC-related issues, ensuring timely closure
Foster a culture of quality, safety, continuous improvement, and cross-functional collaboration with Manufacturing, QA, Engineering, and Supply Chain
Serve as subject matter expert (SME) for QC operations, laboratory systems, analytical and microbiological testing methods, and regulatory compliance requirements
Provide QC input into new product introductions, client onboarding, and lifecycle management activities
Monitor industry trends, regulatory updates, and emerging technologies to identify opportunities for improving QC efficiency, capacity, and quality
Sponsor and lead implementation of process improvements, automation, and digital solutions within QC
Build, develop, and retain a high-performing QC team across Analytical, Microbiology, and Operations functions
Define organizational structure, roles, and career paths to support both site startup and long-term operations
Set clear goals and performance expectations, conducting regular feedback, coaching, and performance reviews
Foster a culture of accountability, teamwork, continuous learning, and employee engagement
Lead by example in demonstrating quality mindset, compliance, and commitment to client satisfaction
Qualification
Required
PhD in Chemistry, Microbiology, Chemical Engineering or related field preferred; master's or bachelor's degree with extensive relevant experience will also be considered
Minimum of 10 years of progressive QC leadership experience in GMP-regulated pharmaceutical or CDMO environments
Proven experience in building or expanding QC operations during site startup or major expansions
Strong knowledge of FDA, EMA, and ICH guidelines and global regulatory expectations
Excellent leadership, communication, and client-facing skills
Company
WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical.
10001+ employees
H1B Sponsorship
WuXi AppTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (1)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.59BKey Investors
Eight Roads Ventures
2025-03-03Acquired
2018-05-08IPO
2016-03-06Debt Financing· $1.5B
Leadership Team
Ge Li
Founder, Chairman and CEO
Recent News
MarketScreener
2025-12-22
South China Morning Post
2025-12-19
Company data provided by crunchbase