What are the responsibilities and job description for the Head of Quality Assurance, Drug Product, GMP QA position at Daiichi Sankyo US?
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Head of Quality Assurance, Drug Product is accountable for the quality oversight of internal sites and Contract Development and Manufacturing Organizations (CDMO).The role leads the site's independent Quality Assurance organization, accountable for an effective, risk based Quality system. The role is responsible for inspection performance/readiness activities, data integrity and accountable to ensure final batch disposition and lot release activities to support patient needs/demand. Partners with Regulatory Affairs, Supply Chain, Tech Unit and global Quality leaders to assure supply and compliance while promoting a culture of continuous improvement. As a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs.
Responsibilities
Quality Operational Oversight and Leadership
Leads a team of 5-7 MSMQ’s that are responsible for leading an independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per Daiichi Sankyo’s GMP Quality Manuals
Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval
Ensure the local QMS remains fully compliant with the global Quality Manual by managing key pillars such as CAPA, change control, and data integrity. Use a risk-based approach to drive periodic reviews and maintain rigorous policy oversight.
Provide hands-on leadership to ensure the seamless execution of Quality Assurance (QA) functions, including complaint management, root-cause investigations, and the reporting of critical GMP issues to senior management.
Direct the batch release process by overseeing complex jurisdiction controls and cross-functional data integration, ensuring all disposition decisions align with Daiichi Sankyo’s Quality digital roadmap and analytics strategy.
Drive a culture of Continuous Improvement (CI) across the site, spearheading initiatives to systematically reduce deviations, shorten manufacturing cycle times, and enhance the robustness of the CAPA (Corrective and Preventive Action) system.
Supports the enhancement of a robust Integrated Risk Management (IRM) framework, identifying potential risks throughout the product lifecycle and implementing proactive mitigation strategies to ensure patient safety and product efficacy.
Represent Quality Assurance in internal and (potentially) external leadership forums and strategic initiatives. Compliance & Regulatory Affairs
Drive institutional adherence to international regulatory frameworks, overseeing the implementation of quality policies that satisfy both domestic and global health authority requirements including but not limited to: cGMP, FDA, EMA, ANVISA, PMDA and ICH guidelines.
Comfortable representing the company to health authorities and expertly navigate difficult audit dynamics with global regulators, ensuring the company’s compliance posture is defended and accurately communicated.
The role includes working cross-functionally with product quality counterparts to ensure an accurate Clinical Trial Document review process People & Culture
Propose resource allocation and MSMQ deployment to Global Manufacturing Quality Head
Partner with HR to oversee talent selection, development, and evaluation of direct reports
Foster a culture of accountability, transparency, and continuous improvement.
Qualifications
Education Qualifications
Bachelor's Degree in a science-related discipline required. An Advanced Degree strongly preferred.
Experience Qualifications
10 or more more years of experience in a specific technical area as Quality Assurance and/or biologics manufacturing in a large multinational pharmaceutical organization required
10 or more years of experience managing a team (preferably global teams covering various countries/time zones), being able to lead across different cultures, build effective teams, develop talents required
Must have extensive experience in audit readiness (including HA audit preparation, conduct mock audits), and risk management required.
Proven expertise in Quality Assurance HA communication, inspection management support for CMO manufacturing at a biologics company required
Demonstrated experience overseeing CMOs (including understanding CMO expectations, capabilities, and challenges) required
Demonstrated experience in one or more of the following: Formulated Bulk, Filling and Finish, secondary packaging processes, current industry best practices for inspection (visual and automated) and their associated materials (e.g. Vials, Syringes, Device Delivery systems, secondary packaging) required
Must have expert knowledge of manufacturing and GMP QA requirements for a specific technical area
Proven ability to problem-solve on quality and supply assurance (including root cause identification and analysis, preventive actions and investigation)
Ability to conduct knowledge transfer (including transfer of institutionalized knowledge, setting up formal structures, onboarding, convening communities of practice, ensuring access to expertise)
Business level English must be strong both written and oral.
Must be able to work cross functionally as a strong collaborator with ability to partner with internal and external stakeholders across multiple global regions
Proen abiity to use sound risk judgment to escalate issues when needed
Travel Requirements
Ability to travel up to 30% of the time globally. Requires flexibility of increased travel dependent on the level of frequency of manufacturing activities at a given CMO.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
USD$226,275.00 - USD$377,125.00
Job Summary
The Head of Quality Assurance, Drug Product is accountable for the quality oversight of internal sites and Contract Development and Manufacturing Organizations (CDMO).The role leads the site's independent Quality Assurance organization, accountable for an effective, risk based Quality system. The role is responsible for inspection performance/readiness activities, data integrity and accountable to ensure final batch disposition and lot release activities to support patient needs/demand. Partners with Regulatory Affairs, Supply Chain, Tech Unit and global Quality leaders to assure supply and compliance while promoting a culture of continuous improvement. As a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs.
Responsibilities
Quality Operational Oversight and Leadership
Leads a team of 5-7 MSMQ’s that are responsible for leading an independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per Daiichi Sankyo’s GMP Quality Manuals
Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval
Ensure the local QMS remains fully compliant with the global Quality Manual by managing key pillars such as CAPA, change control, and data integrity. Use a risk-based approach to drive periodic reviews and maintain rigorous policy oversight.
Provide hands-on leadership to ensure the seamless execution of Quality Assurance (QA) functions, including complaint management, root-cause investigations, and the reporting of critical GMP issues to senior management.
Direct the batch release process by overseeing complex jurisdiction controls and cross-functional data integration, ensuring all disposition decisions align with Daiichi Sankyo’s Quality digital roadmap and analytics strategy.
Drive a culture of Continuous Improvement (CI) across the site, spearheading initiatives to systematically reduce deviations, shorten manufacturing cycle times, and enhance the robustness of the CAPA (Corrective and Preventive Action) system.
Supports the enhancement of a robust Integrated Risk Management (IRM) framework, identifying potential risks throughout the product lifecycle and implementing proactive mitigation strategies to ensure patient safety and product efficacy.
Represent Quality Assurance in internal and (potentially) external leadership forums and strategic initiatives. Compliance & Regulatory Affairs
Drive institutional adherence to international regulatory frameworks, overseeing the implementation of quality policies that satisfy both domestic and global health authority requirements including but not limited to: cGMP, FDA, EMA, ANVISA, PMDA and ICH guidelines.
Comfortable representing the company to health authorities and expertly navigate difficult audit dynamics with global regulators, ensuring the company’s compliance posture is defended and accurately communicated.
The role includes working cross-functionally with product quality counterparts to ensure an accurate Clinical Trial Document review process People & Culture
Propose resource allocation and MSMQ deployment to Global Manufacturing Quality Head
Partner with HR to oversee talent selection, development, and evaluation of direct reports
Foster a culture of accountability, transparency, and continuous improvement.
Qualifications
Education Qualifications
Bachelor's Degree in a science-related discipline required. An Advanced Degree strongly preferred.
Experience Qualifications
10 or more more years of experience in a specific technical area as Quality Assurance and/or biologics manufacturing in a large multinational pharmaceutical organization required
10 or more years of experience managing a team (preferably global teams covering various countries/time zones), being able to lead across different cultures, build effective teams, develop talents required
Must have extensive experience in audit readiness (including HA audit preparation, conduct mock audits), and risk management required.
Proven expertise in Quality Assurance HA communication, inspection management support for CMO manufacturing at a biologics company required
Demonstrated experience overseeing CMOs (including understanding CMO expectations, capabilities, and challenges) required
Demonstrated experience in one or more of the following: Formulated Bulk, Filling and Finish, secondary packaging processes, current industry best practices for inspection (visual and automated) and their associated materials (e.g. Vials, Syringes, Device Delivery systems, secondary packaging) required
Must have expert knowledge of manufacturing and GMP QA requirements for a specific technical area
Proven ability to problem-solve on quality and supply assurance (including root cause identification and analysis, preventive actions and investigation)
Ability to conduct knowledge transfer (including transfer of institutionalized knowledge, setting up formal structures, onboarding, convening communities of practice, ensuring access to expertise)
Business level English must be strong both written and oral.
Must be able to work cross functionally as a strong collaborator with ability to partner with internal and external stakeholders across multiple global regions
Proen abiity to use sound risk judgment to escalate issues when needed
Travel Requirements
Ability to travel up to 30% of the time globally. Requires flexibility of increased travel dependent on the level of frequency of manufacturing activities at a given CMO.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
USD$226,275.00 - USD$377,125.00
Salary : $226,275