Fraser Dove International
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Do you have the right skills and experience for this role Read on to find out, and make your application. Head of Quality Assurance Are you a seasoned QA leader ready to design build and scale Quality Systems for cutting-edge cell therapies? Do you thrive in fast-paced, compliant GMP environments with a focus on digital innovation? Are you passionate about building Quality cultures that drive productivity and patient impact? Fraser Dove International is partnering exclusively with a pioneering cell and gene therapy organisation. Operating in Houston, they are committed to transforming the lives of patients through innovative and life-changing treatments. Our client is seeking a forward-thinking leader to build and scale Quality Assurance operations and systems in support of autologous cell and viral vector manufacturing. Discover more about our Head of Quality Assurance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed. Your objectives: As the Head of Quality Assurance, you will be measured against the following objectives: Develop and scale a compliant, fit-for-purpose Quality System spanning internal development, GMP manufacturing and testing. Lead the optimization of digital Quality platforms and system integrations across enterprise applications. Build a high-performing Quality organisation and culture that enhances compliance, cross-functionality and operational excellence. What you will do: As the Head of Quality Assurance, your duties and responsibilities will include: · Develop and optimize an end-to-end Quality System including materials control, production systems, validation, audits, training, and documentation. · Scale the Quality System to meet growing internal manufacturing and testing demands. · Lead digital transformation across Veeva QualityDocs, QMS, and RIMS, ensuring integration with LIMS, ERP, and EM. · Partner cross-functionally with Manufacturing, Development, QC, Regulatory, and PM to support compliance throughout the development lifecycle. · Develop compliance strategies that enhance productivity by eliminating non-value-added activities. · Build relationships with external academic and biotech partners, leading Quality interactions while preserving internal operational control. · Establish and manage Quality Agreements to maintain external transparency without formal oversight transfer. · Design a scalable Quality organisational structure supporting cross-training and operational robustness. · Foster a proactive, science-based Quality culture across the organisation. What you will bring: These are the skills and experience you will need to succeed as the Head of Quality Assurance: · 12+ years of experience in Quality Assurance for biologics, ideally within cell therapy. · 6+ years of senior leadership experience in managing high-performing QA teams. · Strong knowledge of FDA and global GxP requirements for autologous manufacturing. · Proven experience leading Quality teams through inspections and regulatory engagement. · Proficiency in eQMS platforms, preferably Veeva, with a track record in digital optimisation. · Skilled in risk-based QA strategies and continuous improvement. · Ability to balance compliance with delivery of high-impact therapies to patients. · Strong leadership, team-building, and cross-functional collaboration skills. · Excellent communication, presentation, and interpersonal skills. · BS/MS in a scientific discipline or equivalent combination of education and experience. · Expected to be full-time, on-site. Got what it takes? To apply for the Head of Quality Assurance, click the ‘Apply’ button below or contact the AVP US – [Aidan Russell] – on
+1 305 447 2752 Please Note: · This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments. · If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion. · We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/ Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance, Manufacturing, and Production IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Fraser Dove International by 2x Sign in to set job alerts for “Head of Quality Assurance” roles.Associate Director, Quality Assurance OperationsExecutive Director of Data Governance & Quality Assurance Greater Houston $170,000.00-$195,000.00 2 weeks ago DIRECTOR OF R&D for Heavy Construction Equipment (Mandarin/English required) Houston, TX $176,000.00-$266,200.00 9 hours ago Senior Quality Manager - Supplier Quality Surveillance (SQS)Manufacturing Quality Assurance Technician I - Snack Plant We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Do you have the right skills and experience for this role Read on to find out, and make your application. Head of Quality Assurance Are you a seasoned QA leader ready to design build and scale Quality Systems for cutting-edge cell therapies? Do you thrive in fast-paced, compliant GMP environments with a focus on digital innovation? Are you passionate about building Quality cultures that drive productivity and patient impact? Fraser Dove International is partnering exclusively with a pioneering cell and gene therapy organisation. Operating in Houston, they are committed to transforming the lives of patients through innovative and life-changing treatments. Our client is seeking a forward-thinking leader to build and scale Quality Assurance operations and systems in support of autologous cell and viral vector manufacturing. Discover more about our Head of Quality Assurance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed. Your objectives: As the Head of Quality Assurance, you will be measured against the following objectives: Develop and scale a compliant, fit-for-purpose Quality System spanning internal development, GMP manufacturing and testing. Lead the optimization of digital Quality platforms and system integrations across enterprise applications. Build a high-performing Quality organisation and culture that enhances compliance, cross-functionality and operational excellence. What you will do: As the Head of Quality Assurance, your duties and responsibilities will include: · Develop and optimize an end-to-end Quality System including materials control, production systems, validation, audits, training, and documentation. · Scale the Quality System to meet growing internal manufacturing and testing demands. · Lead digital transformation across Veeva QualityDocs, QMS, and RIMS, ensuring integration with LIMS, ERP, and EM. · Partner cross-functionally with Manufacturing, Development, QC, Regulatory, and PM to support compliance throughout the development lifecycle. · Develop compliance strategies that enhance productivity by eliminating non-value-added activities. · Build relationships with external academic and biotech partners, leading Quality interactions while preserving internal operational control. · Establish and manage Quality Agreements to maintain external transparency without formal oversight transfer. · Design a scalable Quality organisational structure supporting cross-training and operational robustness. · Foster a proactive, science-based Quality culture across the organisation. What you will bring: These are the skills and experience you will need to succeed as the Head of Quality Assurance: · 12+ years of experience in Quality Assurance for biologics, ideally within cell therapy. · 6+ years of senior leadership experience in managing high-performing QA teams. · Strong knowledge of FDA and global GxP requirements for autologous manufacturing. · Proven experience leading Quality teams through inspections and regulatory engagement. · Proficiency in eQMS platforms, preferably Veeva, with a track record in digital optimisation. · Skilled in risk-based QA strategies and continuous improvement. · Ability to balance compliance with delivery of high-impact therapies to patients. · Strong leadership, team-building, and cross-functional collaboration skills. · Excellent communication, presentation, and interpersonal skills. · BS/MS in a scientific discipline or equivalent combination of education and experience. · Expected to be full-time, on-site. Got what it takes? To apply for the Head of Quality Assurance, click the ‘Apply’ button below or contact the AVP US – [Aidan Russell] – on
+1 305 447 2752 Please Note: · This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments. · If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion. · We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/ Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance, Manufacturing, and Production IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Fraser Dove International by 2x Sign in to set job alerts for “Head of Quality Assurance” roles.Associate Director, Quality Assurance OperationsExecutive Director of Data Governance & Quality Assurance Greater Houston $170,000.00-$195,000.00 2 weeks ago DIRECTOR OF R&D for Heavy Construction Equipment (Mandarin/English required) Houston, TX $176,000.00-$266,200.00 9 hours ago Senior Quality Manager - Supplier Quality Surveillance (SQS)Manufacturing Quality Assurance Technician I - Snack Plant We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr