Job summary
Job post source
This job is directly from Azurity Pharmaceuticals
Job overview
The Senior Manager, Quality Systems at Azurity Pharmaceuticals leads the development and maintenance of a compliant Quality Management System to ensure high-quality pharmaceutical products for underserved patients.
Responsibilities and impact
The role involves overseeing electronic quality systems, managing documentation control, leading GxP training, driving continuous improvement initiatives, executing Computer System Validation, and supporting audits and inspections to maintain regulatory compliance.
Compensation and benefits
The position offers a competitive compensation package with an annual bonus, comprehensive health coverage including medical, dental, and vision, a hybrid work model, retirement plan with 401K matching, generous time off including holidays and vacation, tuition reimbursement, and employee recognition programs.
Experience and skills
Candidates should have a bachelor's degree in Life Sciences or related fields, 5-7 years of experience in pharmaceutical quality or regulatory compliance, strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, experience with electronic Document Management Systems, and leadership and project management skills.
Career development
Azurity supports professional growth through tuition reimbursement for courses and certifications, and offers opportunities for continuous learning and career advancement within a growing pharmaceutical company.
Work environment and culture
Azurity values dedication, integrity, and creativity, fostering an inclusive and patient-centric workplace with a hybrid work environment and employee recognition programs.
Company information
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company focusing on innovative products for underserved patients, with a broad commercial portfolio and late-stage pipeline across multiple therapeutic areas.
Team overview
The candidate will join the Documentation Management team responsible for sustaining a robust Quality Management System and ensuring compliance with regulatory standards in a regulated pharmaceutical environment.
Job location and travel
The role offers a hybrid work model with two days remote and three days onsite, excluding certain positions like Sales and Manufacturing.
Unique job features
The job features leadership in maintaining inspection-ready quality systems, managing electronic document systems, and driving compliance with key regulatory standards such as 21 CFR Part 11 and EU Annex 11.
Company overview
Azurity Pharmaceuticals specializes in developing and commercializing innovative, high-quality, and easy-to-use prescription medicines tailored to meet the needs of underserved patient populations, particularly children and the elderly. They generate revenue by creating and marketing proprietary formulations that address unmet medical needs, often focusing on liquid formulations for patients who have difficulty swallowing pills. Founded in 1998, Azurity has grown through strategic acquisitions and partnerships, including the notable acquisition of CutisPharma in 2019, which expanded their portfolio and capabilities in the pharmaceutical compounding space.
How to land this job
Tailor your resume to emphasize leadership in Quality Management Systems and expertise in documentation control within regulated pharmaceutical environments, highlighting compliance with GxP, 21 CFR Part 11, and EU Annex 11.
Showcase your experience managing electronic Document Management Systems and Computer System Validation programs, stressing your ability to maintain inspection-ready quality systems and drive continuous improvement.
Apply via multiple channels including Azurity Pharmaceuticals' corporate careers page and LinkedIn to maximize your application visibility and reach.
Connect with current employees in Azurity’s Quality Systems or Regulatory Affairs divisions on LinkedIn; use ice breakers like commenting on recent company initiatives in quality or asking about their experience with the QMS implementation at Azurity.
Optimize your resume for ATS by incorporating keywords such as 'Quality Management System,' 'documentation management,' 'GxP compliance,' '21 CFR Part 11,' 'EU Annex 11,' and 'Computer System Validation' to ensure your resume passes automated screenings.
Leverage Jennie Johnson’s Power Apply feature to automate tailored applications, identify multiple application portals, and find relevant LinkedIn contacts, enabling you to focus your time on networking and interview preparation.
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