Avecia Pharma
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Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. Select how often (in days) to receive an alert: Create Alert Director, Site Head of Quality Assurance Aug 11, 2025 Regular 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.
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Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. Select how often (in days) to receive an alert: Create Alert Director, Site Head of Quality Assurance Aug 11, 2025 Regular 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.
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