WuXi Biologics · 2 days ago
Associate Director, Cranbury Quality Assurance
Cranbury, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$123K/yr - $209K/yr
10+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The Associate Director of Quality Assurance will lead a team to ensure compliance with regulatory requirements and company standards in manufacturing activities, oversee quality monitoring, and manage quality events and documentation.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead a team to support quality activities in MFG18 and DP12 to ensure all production activities are in compliance with current regulatory requirements, cGMP, and company SOPs
Responsible for review and approval manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, QRM, etc
QA responsible for quality events handling which happened in MFG18 and DP12
QA responsible for on-site quality monitoring of DS/DP, manufacturing, and participant in GMP production activities, such as process transfers, validation, etc
QA responsible for routine audit for manufacturing area, to ensure GMP production in compliance with all regulatory market, EU, FDA, and company standards
Ensure all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes are validated/qualified, operate as per design and are maintained in compliance with Cgmp, industry standards, and regulatory expectations
Ensure all system related Data Integrity activities e.g., system audit trail review, review of user profile and access, all laboratory testing data and related records, including but not limited, assay documentation, instrument cleaning and maintenance records are carried out according to WuXi Quality standards and GMP regulation
Collate and review data to be used in reports, investigations, key performance indicators, and other quality matrices
Other quality activities may be assigned as required
Qualification
Required
Bachelor's degree or higher in Biopharma, biochemistry, chemical engineering, and related life science
Minimum of 10 years' experience working in a biologics or similar GMP environment as part of a quality assurance, quality control, technical services or manufacturing operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
Strong experience in a Quality Engineering/Quality Assurance/Quality Validations Role for Biologics or related pharmaceutical/medical device manufacturing in an FDA/EU regulated environment
Experience and exposure with liaising and responding to regulatory inspectors/client auditors
Strong technical aptitude is required
Previous experience managing a Quality Management System
Experience with GMP processes like good documentation practice, change control, non-conformance management, corrective and preventative actions and SOP writing
Experience in training management, execution, and documentation
Demonstrated understanding of principles of Good Manufacturing and Good Documentation practice
Strong knowledge of GxP regulations (e.g., FDA, EU-GMP Guideline)
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics 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
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
Morningstar.com
2025-12-24
Company data provided by crunchbase