WuXi Biologics
Overview
Job Title - Senior Director, US Quality Control Work Location - Cranbury, NJ 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 of 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.
Job Summary
The US Cranbury Quality Control Head is responsible for overseeing the quality control operations in Cranbury site. This role involves ensuring that all products meet the required standards and regulations, implementing quality control policies, and leading the quality control team to achieve excellence in quality. The position requires a strategic approach to enhance product quality, reduce defects, and ensure customer satisfaction. This role will provide technical leadership to the team to complete various QC functions/tasks to achieve manufacturing needs, project goals and milestones. This role will be responsible for US and global communication from Cranbury site regarding QC functions, participate with the headquarter site with/or other local US and global sites in formulating QC strategy alignment in overall methods platform strategy and promoting new standalone businesses.
Responsibilities
Engage and drive department towards adhering Quality vision, mission, and system. Provide guidance and oversee Analytical (including compendia) and microbiological/raw material testing method qualification/validation progress and status, troubleshooting, laboratory, and OOS investigation. Define operational QC department performance metrics and objectives towards meeting manufacturing and operational goals. Analyze data trends and key performance indicators (KPIs) related to quality, using insights to inform strategic decisions and resource allocation Identifies emerging operation related risks and ensure communication within operational / functional department. Ensure compliance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of GMPs and quality systems with experience managing deviation, change control and CAPA Serve as a quality subject matter expert, representing the organization in external audits, regulatory inspections, and industry forums. Guide and provide expertise to managerial level and junior staff in conducting Laboratory Investigations (LIR) and Out-Of-Specifications (OOS) investigations. Maintain proper budget planning and management in terms of CAPEX and OPEX expenditure for the department as part of company-wide cost control policy. Preparing budget and management of expenditure in line with budget for Quality Control functions and activities. Approval, and where required preparation, of capital expenditure requests for site improvement and renovation projects Lead Quality Control system improvement initiatives and support the integration of WBS (Wuxi Business System) concepts and mechanisms into the QC daily operations. Initiatives such as managing the GEMBA process, Tier 1 accountability board review, editing/approving QC SOPs, designing and advising systems functionality (LIMS, LES, SAP etc.), assisting the internal QC compliance team. Act as an effective communicator of visions, ideas with feasible project goals and targets to internal and cross-functional department team members Recruit, train, and retain a high-performing QC team. Foster a culture of safety, enforce safety measures, and develop employee capabilities in alignment with corporate training and development goals. Provide guidance to people managers in developing respective talent pools, inspire innovation and operational excellence so as to foster a continuous learning and improvement environment. Identify knowledge and skills gaps among director-level QC managers; review and approve training programs to address these gaps; ensure programs encompass essential training in basic Current Good Manufacturing Practices (cGMP), on-the-job training techniques and standard operating procedures; evaluate the competencies of director and manager-level QC staff Participate and engage collaboratively with China/global/local US teams in formulating any Clinical strategies’ alignment in overall methods platform strategy and promoting new standalone businesses. Apply technical knowledge and industry experience to support QC lab design and operational readiness, and lead functional teams in supporting site operations Demonstrate a strong track record of QC leadership supporting commercial-scale manufacturing and regulatory filings (e.g., BLA). Work closely with research and development teams to ensure quality considerations are included in new product design and development. Facilitate risk management activities, including risk assessments and mitigation plans, to anticipate and address potential quality issues. Representing the company to external parties with focus on GMP compliance. Any other tasks assigned by superior (as required).
Qualifications
Ph.D. or M.S. in Biology, Chemistry, Microbiology, or related discipline with at least 15 years of Quality Control experience in the biopharmaceutical industry. More than 10 years of managerial experience in team development and new site establishment. At least 4 years with multiple sites’ managerial experience in a CRDMO company. Knowledge of cGMP standards (Eudralex, CFR, China GMP etc) and various pharmacopeia (ChP, USP, EP, JP etc) and regulatory requirements in the pharmaceutical industry and detailed understanding of the principles and concepts in relations to drug substance development. Expertise in assay development, pharmaceutical analysis, bioassays, impurity testing, microbiology, and stability management. Experience with raw material release, environmental monitoring, biosafety, and cell bank testing. Capable of providing CoA/Batch records and stability data for regulatory submissions and reviewing CMC sections Strong communication skills, good multi-tasking ability, fast learning and competent for fast-pace work environment. Strong awareness of global teamwork with an optimistic work attitude. Willing to travel as required internationally to fulfil the responsibilities of the position. Demonstrated capability and enthusiasm to establish high-performance teams. Excellent communication skills to engage with personnel from multiple disciplines and experience bases across the operations organization. Strong skills in reviewing technical results, troubleshooting, investigations, and CAPA management. Experienced in supporting internal/external audits and regulatory inspections.
The Anticpated pay range for this position is $150,000-$250,000.
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.
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Job Title - Senior Director, US Quality Control Work Location - Cranbury, NJ 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 of 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.
Job Summary
The US Cranbury Quality Control Head is responsible for overseeing the quality control operations in Cranbury site. This role involves ensuring that all products meet the required standards and regulations, implementing quality control policies, and leading the quality control team to achieve excellence in quality. The position requires a strategic approach to enhance product quality, reduce defects, and ensure customer satisfaction. This role will provide technical leadership to the team to complete various QC functions/tasks to achieve manufacturing needs, project goals and milestones. This role will be responsible for US and global communication from Cranbury site regarding QC functions, participate with the headquarter site with/or other local US and global sites in formulating QC strategy alignment in overall methods platform strategy and promoting new standalone businesses.
Responsibilities
Engage and drive department towards adhering Quality vision, mission, and system. Provide guidance and oversee Analytical (including compendia) and microbiological/raw material testing method qualification/validation progress and status, troubleshooting, laboratory, and OOS investigation. Define operational QC department performance metrics and objectives towards meeting manufacturing and operational goals. Analyze data trends and key performance indicators (KPIs) related to quality, using insights to inform strategic decisions and resource allocation Identifies emerging operation related risks and ensure communication within operational / functional department. Ensure compliance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of GMPs and quality systems with experience managing deviation, change control and CAPA Serve as a quality subject matter expert, representing the organization in external audits, regulatory inspections, and industry forums. Guide and provide expertise to managerial level and junior staff in conducting Laboratory Investigations (LIR) and Out-Of-Specifications (OOS) investigations. Maintain proper budget planning and management in terms of CAPEX and OPEX expenditure for the department as part of company-wide cost control policy. Preparing budget and management of expenditure in line with budget for Quality Control functions and activities. Approval, and where required preparation, of capital expenditure requests for site improvement and renovation projects Lead Quality Control system improvement initiatives and support the integration of WBS (Wuxi Business System) concepts and mechanisms into the QC daily operations. Initiatives such as managing the GEMBA process, Tier 1 accountability board review, editing/approving QC SOPs, designing and advising systems functionality (LIMS, LES, SAP etc.), assisting the internal QC compliance team. Act as an effective communicator of visions, ideas with feasible project goals and targets to internal and cross-functional department team members Recruit, train, and retain a high-performing QC team. Foster a culture of safety, enforce safety measures, and develop employee capabilities in alignment with corporate training and development goals. Provide guidance to people managers in developing respective talent pools, inspire innovation and operational excellence so as to foster a continuous learning and improvement environment. Identify knowledge and skills gaps among director-level QC managers; review and approve training programs to address these gaps; ensure programs encompass essential training in basic Current Good Manufacturing Practices (cGMP), on-the-job training techniques and standard operating procedures; evaluate the competencies of director and manager-level QC staff Participate and engage collaboratively with China/global/local US teams in formulating any Clinical strategies’ alignment in overall methods platform strategy and promoting new standalone businesses. Apply technical knowledge and industry experience to support QC lab design and operational readiness, and lead functional teams in supporting site operations Demonstrate a strong track record of QC leadership supporting commercial-scale manufacturing and regulatory filings (e.g., BLA). Work closely with research and development teams to ensure quality considerations are included in new product design and development. Facilitate risk management activities, including risk assessments and mitigation plans, to anticipate and address potential quality issues. Representing the company to external parties with focus on GMP compliance. Any other tasks assigned by superior (as required).
Qualifications
Ph.D. or M.S. in Biology, Chemistry, Microbiology, or related discipline with at least 15 years of Quality Control experience in the biopharmaceutical industry. More than 10 years of managerial experience in team development and new site establishment. At least 4 years with multiple sites’ managerial experience in a CRDMO company. Knowledge of cGMP standards (Eudralex, CFR, China GMP etc) and various pharmacopeia (ChP, USP, EP, JP etc) and regulatory requirements in the pharmaceutical industry and detailed understanding of the principles and concepts in relations to drug substance development. Expertise in assay development, pharmaceutical analysis, bioassays, impurity testing, microbiology, and stability management. Experience with raw material release, environmental monitoring, biosafety, and cell bank testing. Capable of providing CoA/Batch records and stability data for regulatory submissions and reviewing CMC sections Strong communication skills, good multi-tasking ability, fast learning and competent for fast-pace work environment. Strong awareness of global teamwork with an optimistic work attitude. Willing to travel as required internationally to fulfil the responsibilities of the position. Demonstrated capability and enthusiasm to establish high-performance teams. Excellent communication skills to engage with personnel from multiple disciplines and experience bases across the operations organization. Strong skills in reviewing technical results, troubleshooting, investigations, and CAPA management. Experienced in supporting internal/external audits and regulatory inspections.
The Anticpated pay range for this position is $150,000-$250,000.
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.
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