About this opportunity : Reporting to the Senior Director of Quality Control, this role oversees QC at the MAV Cincinnati site. Responsibilities include managing QC systems, ensuring compliance with procedures and data integrity, leading investigations of deviations/OOT/OOS, and ensuring the effectiveness of CAPAs. The Associate Director will champion lean operational practices and foster a culture of efficiency throughout the department. Key Responsibilities: Responsible for managing all activities pertaining to the day-to-day operation of the Raw Material/In-Process/Release testing, Micro/EM testing, and Stability testing, which includes co-ordinate analytical activities between the various QC groups, AD and the Milford QC team. Ensure Right-First Time and On-time Delivery of testing results and documents. Establish and monitor metrics and KPIs to drive continuous performance and operational efficiencies within the QC group to assure budgetary expectations are met. By implementing Lean strategies and leveraging 5S principles, the role ensures that workflow is streamlined, waste is minimized, and every process is optimized for speed and accuracy. Collect feedback from staff, stakeholders, and audits to reinforce the culture of adaptability and responsiveness Provide technical review of procedures to ensure that test methods and specifications are scientifically sound and appropriate for use in QC. Accountable for ensuring that teams deliver against appropriate timelines for quality related issues, including complaints, Deviation, Change Control, and CAPA completions. Ensure repeating issues are caught and given priority for CAPA to prevent it from happening again. Ensure timely and effective interaction with customer representatives as appropriate. Prepare and present department metrics at site Quality Council and Quality Management Review meetings. Develop and drive annual department level goals that support corporate and site based annual goals Foster staff professional growth by coaching and cross-training. Ensure that the knowledge and training for QC staff aligns with evolving global regulations and guidance for pharmaceutical compounds (in general) and oligonucleotides (in particular), and develop appropriate solutions when gaps are identified. Required Skills/Abilities: BS degree with 10+ years' experience in managing a GMP lab or MS degree with 8+ years' experience in chemistry, biology, or related field with 4+ years GMP-QC lab experience. Experience with HPLC, GC, CE, NMR, LCMS, USP testing and Wet Chemistry in a GMP laboratory setting. A thorough knowledge of ICH guidelines as pertaining to specification setting, method transfer and validation, stability study setting up and execution. Leadership skills and experience managing a high-performance team and leading cross- team activities. Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges. The annualized salary range for this role is $135,000.00 - $165,100.00.
10/22/2025
Full time
About this opportunity : Reporting to the Senior Director of Quality Control, this role oversees QC at the MAV Cincinnati site. Responsibilities include managing QC systems, ensuring compliance with procedures and data integrity, leading investigations of deviations/OOT/OOS, and ensuring the effectiveness of CAPAs. The Associate Director will champion lean operational practices and foster a culture of efficiency throughout the department. Key Responsibilities: Responsible for managing all activities pertaining to the day-to-day operation of the Raw Material/In-Process/Release testing, Micro/EM testing, and Stability testing, which includes co-ordinate analytical activities between the various QC groups, AD and the Milford QC team. Ensure Right-First Time and On-time Delivery of testing results and documents. Establish and monitor metrics and KPIs to drive continuous performance and operational efficiencies within the QC group to assure budgetary expectations are met. By implementing Lean strategies and leveraging 5S principles, the role ensures that workflow is streamlined, waste is minimized, and every process is optimized for speed and accuracy. Collect feedback from staff, stakeholders, and audits to reinforce the culture of adaptability and responsiveness Provide technical review of procedures to ensure that test methods and specifications are scientifically sound and appropriate for use in QC. Accountable for ensuring that teams deliver against appropriate timelines for quality related issues, including complaints, Deviation, Change Control, and CAPA completions. Ensure repeating issues are caught and given priority for CAPA to prevent it from happening again. Ensure timely and effective interaction with customer representatives as appropriate. Prepare and present department metrics at site Quality Council and Quality Management Review meetings. Develop and drive annual department level goals that support corporate and site based annual goals Foster staff professional growth by coaching and cross-training. Ensure that the knowledge and training for QC staff aligns with evolving global regulations and guidance for pharmaceutical compounds (in general) and oligonucleotides (in particular), and develop appropriate solutions when gaps are identified. Required Skills/Abilities: BS degree with 10+ years' experience in managing a GMP lab or MS degree with 8+ years' experience in chemistry, biology, or related field with 4+ years GMP-QC lab experience. Experience with HPLC, GC, CE, NMR, LCMS, USP testing and Wet Chemistry in a GMP laboratory setting. A thorough knowledge of ICH guidelines as pertaining to specification setting, method transfer and validation, stability study setting up and execution. Leadership skills and experience managing a high-performance team and leading cross- team activities. Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges. The annualized salary range for this role is $135,000.00 - $165,100.00.
About this opportunity : As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits. Key Job Responsibilities: Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction. Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations. Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition. Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement. Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making. Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.). Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation. Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance. Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations. Build and maintain strong relationships with client quality counterparts. Lead, mentor, and develop the QA team to ensure capability, performance, and career growth. Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement. Required Skills/Abilities: Advanced scientific degree in Pharmacy, Chemistry, Biotechnology, or related life sciences discipline preferred, or bachelor's degree with significant relevant experience. Minimum of 12-15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred. At least 10 years of quality assurance experience, including a minimum of 5 years in a management role with direct site-level quality responsibility. Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization. Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. Strong knowledge and experience implementing/enforcing ICH Q guidelines, and regulatory guidance documents related to process and computerized system validation. Strong critical thinking and decision-making skills. Excellent organizational, planning, and communication skills. Effective time management skills to support rapid business growth. Ability to lead, motivate, coach, and train team members and non-quality personnel effectively. Must be able to effectively interact with subordinates, customers, regulatory agencies, and peers to resolve problems and establish procedures. The annualized salary range for this position is $171,800.00 - $210,100.00.
10/22/2025
Full time
About this opportunity : As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits. Key Job Responsibilities: Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction. Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations. Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition. Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement. Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making. Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.). Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation. Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance. Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations. Build and maintain strong relationships with client quality counterparts. Lead, mentor, and develop the QA team to ensure capability, performance, and career growth. Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement. Required Skills/Abilities: Advanced scientific degree in Pharmacy, Chemistry, Biotechnology, or related life sciences discipline preferred, or bachelor's degree with significant relevant experience. Minimum of 12-15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred. At least 10 years of quality assurance experience, including a minimum of 5 years in a management role with direct site-level quality responsibility. Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization. Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. Strong knowledge and experience implementing/enforcing ICH Q guidelines, and regulatory guidance documents related to process and computerized system validation. Strong critical thinking and decision-making skills. Excellent organizational, planning, and communication skills. Effective time management skills to support rapid business growth. Ability to lead, motivate, coach, and train team members and non-quality personnel effectively. Must be able to effectively interact with subordinates, customers, regulatory agencies, and peers to resolve problems and establish procedures. The annualized salary range for this position is $171,800.00 - $210,100.00.
About this opportunity : As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits. Key Job Responsibilities: Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction. Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations. Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition. Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement. Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making. Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.). Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation. Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance. Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations. Build and maintain strong relationships with client quality counterparts. Lead, mentor, and develop the QA team to ensure capability, performance, and career growth. Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement. Required Skills/Abilities: Advanced scientific degree in Pharmacy, Chemistry, Biotechnology, or related life sciences discipline preferred, or bachelor's degree with significant relevant experience. Minimum of 12-15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred. At least 10 years of quality assurance experience, including a minimum of 5 years in a management role with direct site-level quality responsibility. Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization. Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. Strong knowledge and experience implementing/enforcing ICH Q guidelines, and regulatory guidance documents related to process and computerized system validation. Strong critical thinking and decision-making skills. Excellent organizational, planning, and communication skills. Effective time management skills to support rapid business growth. Ability to lead, motivate, coach, and train team members and non-quality personnel effectively. Must be able to effectively interact with subordinates, customers, regulatory agencies, and peers to resolve problems and establish procedures. The annualized salary range for this position is $171,800.00 - $210,100.00.
10/06/2025
Full time
About this opportunity : As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits. Key Job Responsibilities: Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction. Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations. Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition. Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement. Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making. Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.). Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation. Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance. Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations. Build and maintain strong relationships with client quality counterparts. Lead, mentor, and develop the QA team to ensure capability, performance, and career growth. Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement. Required Skills/Abilities: Advanced scientific degree in Pharmacy, Chemistry, Biotechnology, or related life sciences discipline preferred, or bachelor's degree with significant relevant experience. Minimum of 12-15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred. At least 10 years of quality assurance experience, including a minimum of 5 years in a management role with direct site-level quality responsibility. Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization. Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. Strong knowledge and experience implementing/enforcing ICH Q guidelines, and regulatory guidance documents related to process and computerized system validation. Strong critical thinking and decision-making skills. Excellent organizational, planning, and communication skills. Effective time management skills to support rapid business growth. Ability to lead, motivate, coach, and train team members and non-quality personnel effectively. Must be able to effectively interact with subordinates, customers, regulatory agencies, and peers to resolve problems and establish procedures. The annualized salary range for this position is $171,800.00 - $210,100.00.