Quality & Compliance Manager – Compounding Pharmacy at Remedy · LumiJobs

Qualification

Track record trending microbial dataPCAB (ACHC) accreditation experiencePhysical Requirements

Required

5+ years in sterile compounding with real accountability for the quality system. You have been responsible for it, not adjacent to it
Demonstrated experience designing or substantially rebuilding an EM program, including sampling rationale and action-level setting
Track record trending microbial data, calling an excursion, and defending that call to someone who didn’t want to hear it
Direct experience with pharmacy regulatory compliance beyond USP – licensure, DEA, multistate operations
SOP authorship and hands-on owners of a formal deviation/CAPA and change-control system
Experience being questioned by an inspector about your records
Strong verbal and written communication skills, with the ability to train staff clearly and build relationships with regulators, leadership, and cross-functional teams
Well developed organizational and time management skills; comfortable managing multiple open investigations and audit preparations simultaneously
Certified in Healthcare Compliance (CHC), RAPS RAC, ASQ CQA, or CPHQ
CriticalPoint or ASHP sterile compounding training certificate
PCAB (ACHC) accreditation experience, or cGMP quality-system exposure from a 503B or manufacturer
Multistate nonresident pharmacy licensure management at scale

Preferred

Physical Requirements
All Company policies and procedures are subject to change without notice based on business needs. This includes, but is not limited to, the locations where we hire remote, hybrid, or onsite employees.
U.S. Applicants Only
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Remedy we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions. Contact us at recruiting@thirtymadison.com to request accommodation.
*This employer participates in E-Verify and will provide the federal government with your I-9 Form information to confirm that you are authorized to work in the U.S.*
*Please be aware that there are fraudulent entities who are falsely claiming to be or represent Remedy in order to solicit sensitive personal information or payment. Remedy is not in any way associated with these entities or practices. The safety and integrity of those seeking employment with us is of the utmost importance and we actively work with our legal and security teams to prevent future incidents.

Quality & Compliance Manager – Compounding Pharmacy

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Remedy

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