BeiGene, Ltd.
Associate Director Quality Assurance Compliance, Hopewell NJ Site
BeiGene, Ltd., Hopewell, Virginia, United States, 23860
Associate Director Quality Assurance Compliance, Hopewell NJ Site
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. Apply locations: Hopewell | Time type: Full time | Posted on: Posted 19 Days Ago | Job requisition id: R27824 BeOne continues to grow rapidly, offering challenging opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer. General Description: Responsible for designing, implementing, and managing Compliance programs at the Hopewell, NJ site. These include, but are not limited to, market action, self-inspection, Health Authority inspection preparation, annual reporting, deviation/complaint/CAPA management, and vendor qualification. The role involves managing these systems daily to support clinical and commercial manufacturing, with some travel possible. Essential Functions: Develop and implement Compliance programs aligned with business needs and departmental goals. Determine appropriate quality KPIs for clinical and commercial operations. Collaborate with vendors on Quality Assurance Agreements and vendor qualification. Develop SOPs ensuring regulatory compliance for clinical and commercial activities. Ensure activities comply with GMP, SOPs, and safety policies. Ensure adequate resources for QMS programs. Develop programs for Deviation Management and Self-Inspection. Investigate discrepancies, errors, complaints, failures, or adverse events. Participate in regulatory and customer inspections/audits. Serve as subject matter expert in GMPs: 21 CFR 210, 211, 600; knowledgeable about EU ATMPs. Supervise and mentor staff, ensuring compliance and development. Partner with operations on raw material and component needs. Perform other duties as assigned by QA leadership. This is a site-based position. Core Competencies, Knowledge, and Skills: Scientific degree (chemistry, biology, biotech, pharma, or related). At least 8 years in QA/QC within FDA-regulated biotech/pharma, with increasing responsibility. Minimum 5 years in people management. Deep knowledge of pharmaceutical QMS. Experience with vendor qualification and audit programs. Knowledge of manufacturing processes for clinical and commercial products, including large and small molecules. Strong leadership, communication, strategic thinking, and customer focus. Analytical, problem-solving skills, and a proactive attitude. Excellent attention to detail, time management, and self-motivation. Desirable IT skills: Microsoft Office, SAP knowledge preferred. Significant Contacts: Interact with Supply Chain, Technical, and Operational departments. Engage with BeiGene Global Quality. Supervisory Responsibilities: Manage direct reports at the Hopewell, NJ site. Computer Skills: Proficient in MS Office; SAP QM knowledge is a plus. Education Required: Bachelor's degree in a related scientific discipline. Travel: Willing to travel approximately 10% as needed. Global Competencies: Exhibit values of Patients First, Driving Excellence, Bold Ingenuity, and Collaboration through competencies like teamwork, feedback, inclusivity, initiative, learning, change adaptation, results orientation, analytical thinking, financial excellence, and clear communication. Salary Range: $137,200 - $187,200 annually BeOne offers fair compensation, benefits, and opportunities for stock ownership and bonuses. We are an equal opportunity employer, committed to diversity and inclusion. For accommodations, contact accommodationsus@beonemed.com.
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Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. Apply locations: Hopewell | Time type: Full time | Posted on: Posted 19 Days Ago | Job requisition id: R27824 BeOne continues to grow rapidly, offering challenging opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer. General Description: Responsible for designing, implementing, and managing Compliance programs at the Hopewell, NJ site. These include, but are not limited to, market action, self-inspection, Health Authority inspection preparation, annual reporting, deviation/complaint/CAPA management, and vendor qualification. The role involves managing these systems daily to support clinical and commercial manufacturing, with some travel possible. Essential Functions: Develop and implement Compliance programs aligned with business needs and departmental goals. Determine appropriate quality KPIs for clinical and commercial operations. Collaborate with vendors on Quality Assurance Agreements and vendor qualification. Develop SOPs ensuring regulatory compliance for clinical and commercial activities. Ensure activities comply with GMP, SOPs, and safety policies. Ensure adequate resources for QMS programs. Develop programs for Deviation Management and Self-Inspection. Investigate discrepancies, errors, complaints, failures, or adverse events. Participate in regulatory and customer inspections/audits. Serve as subject matter expert in GMPs: 21 CFR 210, 211, 600; knowledgeable about EU ATMPs. Supervise and mentor staff, ensuring compliance and development. Partner with operations on raw material and component needs. Perform other duties as assigned by QA leadership. This is a site-based position. Core Competencies, Knowledge, and Skills: Scientific degree (chemistry, biology, biotech, pharma, or related). At least 8 years in QA/QC within FDA-regulated biotech/pharma, with increasing responsibility. Minimum 5 years in people management. Deep knowledge of pharmaceutical QMS. Experience with vendor qualification and audit programs. Knowledge of manufacturing processes for clinical and commercial products, including large and small molecules. Strong leadership, communication, strategic thinking, and customer focus. Analytical, problem-solving skills, and a proactive attitude. Excellent attention to detail, time management, and self-motivation. Desirable IT skills: Microsoft Office, SAP knowledge preferred. Significant Contacts: Interact with Supply Chain, Technical, and Operational departments. Engage with BeiGene Global Quality. Supervisory Responsibilities: Manage direct reports at the Hopewell, NJ site. Computer Skills: Proficient in MS Office; SAP QM knowledge is a plus. Education Required: Bachelor's degree in a related scientific discipline. Travel: Willing to travel approximately 10% as needed. Global Competencies: Exhibit values of Patients First, Driving Excellence, Bold Ingenuity, and Collaboration through competencies like teamwork, feedback, inclusivity, initiative, learning, change adaptation, results orientation, analytical thinking, financial excellence, and clear communication. Salary Range: $137,200 - $187,200 annually BeOne offers fair compensation, benefits, and opportunities for stock ownership and bonuses. We are an equal opportunity employer, committed to diversity and inclusion. For accommodations, contact accommodationsus@beonemed.com.
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