WuXi Biologics · 3 days ago
Associate Director, Worcester Quality Assurance
Worcester, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$110K/yr - $195K/yr
7+ 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. The Associate Director of Quality Assurance will develop and implement a quality management system, ensure compliance with regulations, and lead a high-performing quality team.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop and implement a robust quality management system (QMS) for the new site, ensuring compliance with all applicable regulations and industry standards
Create and maintain comprehensive quality documentation, including quality manuals, SOPs, and guidance documents
Lead qualification and validation efforts for facilities, utilities, equipment, and instrumentation
Provide onsite support for Factory Acceptance Testing (FAT) activities, collaborating closely with Engineering and Manufacturing teams
Develop and implement QA protocols for QC processes
Conduct regular audits of QC procedures to ensure compliance with regulatory standards
Identify areas for improvement and work with QC teams to implement corrective actions
Maintain accurate and up-to-date documentation of QC processes and QA audits
Ensure all QC documentation meets regulatory requirements and company standards
Provide training to QC staff on QA protocols and best practices
Ensure QC staff are knowledgeable about regulatory requirements and company policies
Monitor QC processes to ensure compliance with industry regulations and standards
Stay updated on changes in regulatory requirements and ensure QC processes are adjusted accordingly
Recruit, train, and manage a high-performing Quality team
Foster a strong, proactive quality culture emphasizing accountability, continuous improvement, and compliance
Collaborate closely with internal stakeholders including R&D, Engineering, Manufacturing, and Regulatory Affairs to ensure alignment on quality objectives
Clearly communicate quality goals, progress, challenges, and solutions to senior management and stakeholders
Develop and manage budgets for Quality Assurance activities
Plan and justify capital expenditures related to quality improvements and compliance
Ensure ongoing compliance with regulatory requirements through audits, inspections, and internal assessments
Drive continuous improvement initiatives and operational excellence within quality processes
Participate in strategic planning for organizational growth from a quality assurance perspective
Provide leadership and guidance in quality assurance matters to internal and external stakeholders
Oversee risk assessment and mitigation planning to proactively address potential quality issues
Manage the performance, professional growth, and development of Quality Assurance personnel
Conduct regular performance evaluations, provide coaching, and ensure staff have clear goals and development paths
Review and approve critical quality documentation, including validation protocols, SOPs, and technical reports
Qualification
Required
Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or related fields
Minimum 7 years of experience in the Pharmaceutical/Biopharmaceutical industry
Minimum 5 years of experience in Quality related roles
Proven experience with quality systems implementation, facility and instrument qualification, and onsite support for FAT activities
Experience in building and managing quality teams and fostering a strong quality culture
Familiarity with regulatory requirements including FDA, EMA, CFDA GMP regulations, Pharmacopoeias, and ICH guidelines
Strong communication skills, stakeholder management experience, and budget planning capabilities
Strong knowledge of GMP standards and regulatory compliance requirements
Ability to effectively manage multiple projects and priorities simultaneously
Excellent analytical, problem-solving, and decision-making skills
Experience with internal audits, external inspections, and regulatory interactions
Strong interpersonal skills with the ability to build effective relationships across all levels
Occasional travel may be required
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