Director – Quality, Standards & Training
Azurity Pharmaceuticals, Raleigh, NC, United States
Director – Quality, Standards & Training
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high‑quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late‑stage pipeline. The company’s patient‑centric products span the cardiovascular, neurology, endocrinology, gastro‑intestinal, institutional, and orphan markets, and have benefited millions of patients.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Azurity Pharmaceuticals
is seeking a Director of Quality, Standards & Training to lead drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in ensuring compliance, leadership oversight, and maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.
Reporting to the Vice President, Global Drug Safety , this director‑level role will work closely with Drug Safety Operations, Compliance, Quality, and cross‑functional partners to lead SOP management, training coordination, and continuous improvement initiatives.
Responsibilities
Lead the global drug safety quality and training strategy, ensuring compliance with regulatory authority requirements.
Design, implement and oversee a risk‑based Quality Management System (QMS) for drug safety including SOP governance, deviation management, CAPAs, inspection readiness and audit support.
Develop and maintain a comprehensive drug safety framework including onboarding, role‑based curricula, annual compliance training and vendor/partner training oversight.
Drive inspection readiness and audit excellence serve as the Drug Safety Quality lead during internal audits, partner audits and regulatory inspections.
Establish KPIs and quality metrics to monitor compliance.
Partner cross‑functionally with teams to ensure alignment of safety processes, and training adherence.
Lead and develop a high‑performing Quality & Training Team, fostering a culture of accountability, continuous improvement and operational excellence within drug safety.
Qualifications and Education Requirements
10 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
Leadership experience and oversight of drug safety compliance, CAPAs, deviations and change controls.
Advanced understanding of global regulations and experience leading audits.
Physical & Mental Requirements
Must be able to sit for long periods of time.
While performing the duties of this job, the employee is frequently required to stand, walk, sit, talk and/or hear.
May occasionally climb stairs and/or ride elevators.
The employee must occasionally lift and/or move up to 25 pounds.
Employee must be able to manipulate keyboard, operate a telephone and hand‑held devices.
Other miscellaneous job duties as required.
Benefits We Offer
Competitive salary, annual bonus based on company performance, and an incentive compensation program for sales personnel.
Health coverage including medical, dental, vision and prescription plans.
Hybrid work model—two days from home, three days in the office (excludes Sales, Manufacturing, and some Operations positions).
401(k) retirement savings plan with dollar‑for‑dollar matching up to 5%.
Generous paid time off—up to 15 vacation days annually plus rollover up to 40 hours, plus five sick/wellness days; vacation accrual prorated for new employees.
Company holiday schedule: 13 holidays per year and a one‑week break between Christmas and New Year’s.
Tuition reimbursement for undergraduate and graduate level courses or certifications.
Peer recognition platform “High Five” for celebrating accomplishments.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
As set forth in Azurity Pharmaceuticals – US’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
#J-18808-Ljbffr
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Azurity Pharmaceuticals
is seeking a Director of Quality, Standards & Training to lead drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in ensuring compliance, leadership oversight, and maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.
Reporting to the Vice President, Global Drug Safety , this director‑level role will work closely with Drug Safety Operations, Compliance, Quality, and cross‑functional partners to lead SOP management, training coordination, and continuous improvement initiatives.
Responsibilities
Lead the global drug safety quality and training strategy, ensuring compliance with regulatory authority requirements.
Design, implement and oversee a risk‑based Quality Management System (QMS) for drug safety including SOP governance, deviation management, CAPAs, inspection readiness and audit support.
Develop and maintain a comprehensive drug safety framework including onboarding, role‑based curricula, annual compliance training and vendor/partner training oversight.
Drive inspection readiness and audit excellence serve as the Drug Safety Quality lead during internal audits, partner audits and regulatory inspections.
Establish KPIs and quality metrics to monitor compliance.
Partner cross‑functionally with teams to ensure alignment of safety processes, and training adherence.
Lead and develop a high‑performing Quality & Training Team, fostering a culture of accountability, continuous improvement and operational excellence within drug safety.
Qualifications and Education Requirements
10 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
Leadership experience and oversight of drug safety compliance, CAPAs, deviations and change controls.
Advanced understanding of global regulations and experience leading audits.
Physical & Mental Requirements
Must be able to sit for long periods of time.
While performing the duties of this job, the employee is frequently required to stand, walk, sit, talk and/or hear.
May occasionally climb stairs and/or ride elevators.
The employee must occasionally lift and/or move up to 25 pounds.
Employee must be able to manipulate keyboard, operate a telephone and hand‑held devices.
Other miscellaneous job duties as required.
Benefits We Offer
Competitive salary, annual bonus based on company performance, and an incentive compensation program for sales personnel.
Health coverage including medical, dental, vision and prescription plans.
Hybrid work model—two days from home, three days in the office (excludes Sales, Manufacturing, and some Operations positions).
401(k) retirement savings plan with dollar‑for‑dollar matching up to 5%.
Generous paid time off—up to 15 vacation days annually plus rollover up to 40 hours, plus five sick/wellness days; vacation accrual prorated for new employees.
Company holiday schedule: 13 holidays per year and a one‑week break between Christmas and New Year’s.
Tuition reimbursement for undergraduate and graduate level courses or certifications.
Peer recognition platform “High Five” for celebrating accomplishments.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
As set forth in Azurity Pharmaceuticals – US’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
#J-18808-Ljbffr