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. For more information, visit www.azurity.com.
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.
Brief team/department description:
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.
Principle Responsibilities:
- Lead the global drug safety quality and training strategy, ensuring compliance with regulatory authority requirements.
- Design, implement and oversee a reisk-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 withing 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.
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Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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:
- Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
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