WuXi AppTec · 2 weeks ago
Quality Assurance Manager/Sr. Manager - Pharmaceuticals
Middletown, DE
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expWuXi AppTec is a global CRDMO leader enabling healthcare innovation worldwide. The Quality Assurance Manager/Sr. Manager will lead the implementation and maintenance of the Quality Management Systems at the new manufacturing facility, ensuring compliance with regulatory requirements and driving commercial success.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Directly supervise, mentor, and develop a team of quality professionals, including assigning tasks, conducting performance reviews, and fostering professional growth to build a high-performing quality function
Lead the implementation of total quality management, approximately 40 operations and quality systems, at the new manufacturing site, including developing and documenting processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies
Review and approve facility, utility and equipment CQV documentation such as VMP, URS, FAT, SAT, turnover packages, installation/operation/performance qualifications, and process validations
Conduct readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate potential quality risks prior to operational startup
Plan, execute, and report on internal audits to assess compliance with QMS standards, identifying areas for improvement and ensuring timely resolution
Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation, coordinating site tours, and responding to inquiries
Manage the follow-up on audit findings, observations, and deviations through the CAPA process, including root cause analysis, action plan development, implementation, and verification of effectiveness
Create and support employee training programs on quality systems, GMP, and related topics to foster a culture of quality and compliance
Assist in the review of batch records for accuracy and completeness, contributing to product disposition decisions as needed
Assist in all municipal, federal and foreign compliance matters to gain and maintain approvals for commercial GMP production
Support deviation investigations and review and approve QMS documents such as change control, deviation reports, CAPA, continuous improvements, and effectiveness checks
Collaborate with cross-functional teams (e.g., manufacturing, engineering, and regulatory affairs) to integrate quality principles into daily operations
Maintain accurate records and documentation in compliance with data integrity standards
Stay current with industry trends, regulatory updates, and best practices in pharmaceutical quality management
Qualification
Required
Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field
Minimum of 10 years of experience in pharmaceutical quality assurance, preferably in various dosage forms such as solid oral dose and small molecule sterile injectables
Proven experience in QMS implementation, internal auditing, and managing regulatory audits
Strong knowledge of GMP, ICH guidelines, ISO, and ISPE guidelines
Certifications in auditing and quality management from ASQ or other professional organizations
Excellent analytical, problem-solving, and communication skills, with the ability to influence stakeholders at all levels
Proficiency in quality management software and Microsoft Office Suite
Ability to work independently and as part of a team in a regulated, high-pressure environment
Willingness to travel occasionally for audits or training
Preferred
Experience in a greenfield manufacturing site startup
Experience in OPEX and Lean Six Sigma concepts
Experience in OSD manufacturing processes
Familiarity with aseptic processing and sterile product manufacturing
Training certification (e.g., in GMP or quality systems)
Knowledge of risk management tools (e.g., FMEA)
Knowledge of quality engineering and statistical process control concepts
Benefits
Competitive salary
Comprehensive benefits
Opportunities for professional growth
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
CEO
Recent News
South China Morning Post
2026-01-23
Morningstar.com
2026-01-19
2026-01-15
Company data provided by crunchbase