Daiichi Sankyo US
Associate Director, Global Quality Audit
Daiichi Sankyo US, Basking Ridge, New Jersey, us, 07920
Associate Director, Global Quality Audit
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Overview Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary Accountable to organize and direct an audit universe for GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons learned from audits/inspections to drive continuous improvement, support or lead due‑diligence assessments of GMP facilities and/or CMOs, ensure inspection readiness, and support regulatory inspection activities at DS facilities and/or CMOs. The incumbent will demonstrate ability to transform the organization into a proactive learning organization through lessons learned from audits, assessments, inspections, metrics, deviations and process improvements.
Responsibilities
Support the completion of GMP audit and vendor qualification program by creating audit plans, organizing audit schedule, monitoring completion of CAPA plans, and managing metrics. Monitor vendor performance management program, issue audit plans, agenda, and reports.
Ensure risk management activities completion for vendors and periodically review vendor performance according to local procedures and standards.
Create and maintain a database on vendor and supplier quality status; evaluate and communicate metrics to QA functions and DS Global QA organization.
Develop procedural documents and SOPs for QA GMP audit processes; support training activities for QA GxP functions.
Collaborate with QA GMP organization in local, regional, and global audit activities; support standard definition, training, and capacitation programs for GMP QA auditors.
Communicate clearly and timely with suppliers to address issues, provide proactive solutions, and manage stakeholder risks.
Create an atmosphere of trust, integrity, and ethics.
Qualifications
Bachelor’s Degree in a scientific discipline required; Master’s or advanced degree preferred.
At least 7 years of experience in pharmaceutical industry or biological operations, including drug manufacturing, packaging, QA, compliance, and audit.
Expertise with various pharmaceutical dosage forms, especially biologics.
Solid understanding of quality management and continuous process improvement principles, including global cGMP requirements.
Preferred certifications in Pharmaceutical Quality Engineering, Auditing, and/or Quality Management.
Travel Ability to travel up to 30% domestically and globally.
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 under law.
Salary Range $150,800.00 – $226,200.00
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Overview Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary Accountable to organize and direct an audit universe for GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons learned from audits/inspections to drive continuous improvement, support or lead due‑diligence assessments of GMP facilities and/or CMOs, ensure inspection readiness, and support regulatory inspection activities at DS facilities and/or CMOs. The incumbent will demonstrate ability to transform the organization into a proactive learning organization through lessons learned from audits, assessments, inspections, metrics, deviations and process improvements.
Responsibilities
Support the completion of GMP audit and vendor qualification program by creating audit plans, organizing audit schedule, monitoring completion of CAPA plans, and managing metrics. Monitor vendor performance management program, issue audit plans, agenda, and reports.
Ensure risk management activities completion for vendors and periodically review vendor performance according to local procedures and standards.
Create and maintain a database on vendor and supplier quality status; evaluate and communicate metrics to QA functions and DS Global QA organization.
Develop procedural documents and SOPs for QA GMP audit processes; support training activities for QA GxP functions.
Collaborate with QA GMP organization in local, regional, and global audit activities; support standard definition, training, and capacitation programs for GMP QA auditors.
Communicate clearly and timely with suppliers to address issues, provide proactive solutions, and manage stakeholder risks.
Create an atmosphere of trust, integrity, and ethics.
Qualifications
Bachelor’s Degree in a scientific discipline required; Master’s or advanced degree preferred.
At least 7 years of experience in pharmaceutical industry or biological operations, including drug manufacturing, packaging, QA, compliance, and audit.
Expertise with various pharmaceutical dosage forms, especially biologics.
Solid understanding of quality management and continuous process improvement principles, including global cGMP requirements.
Preferred certifications in Pharmaceutical Quality Engineering, Auditing, and/or Quality Management.
Travel Ability to travel up to 30% domestically and globally.
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 under law.
Salary Range $150,800.00 – $226,200.00
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