<p>Job Title - Associate Director, Worcester Quality Assurance</p> <p>Work Location - Worcester MA</p> <p>WuXi 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. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.</p> <p>Responsibilites</p> <p>Quality System Establishment:</p> <ul> <li>Develop and implement a robust quality management system (QMS) for the new site, ensuring compliance with all applicable regulations and industry standards. </li><li>Create and maintain comprehensive quality documentation, including quality manuals, SOPs, and guidance documents. </li></ul> <p>Facility and Instrument Qualification:</p> <ul> <li>Lead qualification and validation efforts for facilities, utilities, equipment, and instrumentation. </li><li>Provide onsite support for Factory Acceptance Testing (FAT) activities, collaborating closely with Engineering and Manufacturing teams. </li></ul> <p>Quality Assurance:</p> <ul> <li>Develop and implement QA protocols for QC processes. </li><li>Conduct regular audits of QC procedures to ensure compliance with regulatory standards. </li><li>Identify areas for improvement and work with QC teams to implement corrective actions </li></ul> <p>Documentation:</p> <ul> <li>Maintain accurate and up-to-date documentation of QC processes and QA audits. </li><li>Ensure all QC documentation meets regulatory requirements and company standards. </li></ul> <p>Training:</p> <ul> <li>Provide training to QC staff on QA protocols and best practices. </li><li>Ensure QC staff are knowledgeable about regulatory requirements and company policies. </li></ul> <p>Compliance:</p> <ul> <li>Monitor QC processes to ensure compliance with industry regulations and standards. </li><li>Stay updated on changes in regulatory requirements and ensure QC processes are adjusted accordingly. </li></ul> <p>Team and Culture Development:</p> <ul> <li>Recruit, train, and manage a high-performing Quality team. </li><li>Foster a strong, proactive quality culture emphasizing accountability, continuous improvement, and compliance. </li></ul> <p>Stakeholder Engagement and Communication:</p> <ul> <li>Collaborate closely with internal stakeholders including R&D, Engineering, Manufacturing, and Regulatory Affairs to ensure alignment on quality objectives. </li><li>Clearly communicate quality goals, progress, challenges, and solutions to senior management and stakeholders. </li></ul> <p>Budget and Resource Planning:</p> <ul> <li>Develop and manage budgets for Quality Assurance activities. </li><li>Plan and justify capital expenditures related to quality improvements and compliance. </li></ul> <p>Compliance and Continuous Improvement:</p> <ul> <li>Ensure ongoing compliance with regulatory requirements through audits, inspections, and internal assessments. </li><li>Drive continuous improvement initiatives and operational excellence within quality processes. </li></ul> <p>Strategic Support:</p> <ul> <li>Participate in strategic planning for organizational growth from a quality assurance perspective. </li><li>Provide leadership and guidance in quality assurance matters to internal and external stakeholders. </li><li>Oversee risk assessment and mitigation planning to proactively address potential quality issues. </li></ul> <p>Leadership and Performance Management:</p> <ul> <li>Manage the performance, professional growth, and development of Quality Assurance personnel. </li><li>Conduct regular performance evaluations, provide coaching, and ensure staff have clear goals and development paths. </li></ul> <p>Document Review and Approval:</p> <ul> <li>Review and approve critical quality documentation, including validation protocols, SOPs, and technical reports. </li></ul> <p>Qualifications</p> <ul> <li>Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or related fields. </li><li>Minimum 7 years of experience in the Pharmaceutical/Biopharmaceutical industry. </li><li>Minimum 5 years of experience in Quality related roles. </li><li>Proven experience with quality systems implementation, facility and instrument qualification, and onsite support for FAT activities. </li><li>Experience in building and managing quality teams and fostering a strong quality culture. </li><li>Familiarity with regulatory requirements including FDA, EMA, CFDA GMP regulations, Pharmacopoeias, and ICH guidelines. </li><li>Strong communication skills, stakeholder management experience, and budget planning capabilities </li><li>Strong knowledge of GMP standards and regulatory compliance requirements. </li><li>Ability to effectively manage multiple projects and priorities simultaneously. </li><li>Excellent analytical, problem-solving, and decision-making skills. </li><li>Experience with internal audits, external inspections, and regulatory interactions. </li><li>Strong interpersonal skills with the ability to build effective relationships across all level </li><li>Occasional travel may be required. </li></ul> <p>The anticpated pay range for this position is $110k-195k</p> <p>The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.</p> <p>WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability</p>