You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Quality Manager to oversee GxP training compliance and manage the Electronic Learning Management System (eLMS) for training assignments, tracking, and onboarding/offboarding support. The role involves managing regulatory intelligence activities, supporting document control processes, and serving as an eQMS Administrator. The Quality Manager will handle product quality complaints and provide general Quality Systems support to QA and CMC teams.

Key Responsibilities

• Oversee GxP training compliance and serve as the eLMS Administrator.
• Manage regulatory intelligence activities, monitoring updates and communicating relevant changes to Quality and cross-functional teams.
• Support document control processes, including procedural reviews and issuance/obsolescence of procedures.
• Serve as eQMS Administrator, maintaining system access, upgrades, and change control initiation.
• Manage product quality complaints, including intake, case initiation, reconciliation, and vendor/CMO communication.
• Provide general Quality Systems support to QA and CMC teams as needed.

Qualifications

• 3-5 years of Quality Systems pharma experience.
• Prior experience in pharmaceutical quality systems and proficiency with Veeva are essential.
• Veeva proficiency.
• BS Degree preferred.
• Prior experience with ComplianceWire is strongly preferred.

Experience

• 3-5 years in pharmaceutical Quality Systems.
• Specific experience in using Veeva and ComplianceWire.

Skills

• Proficiency in Veeva and other Quality Systems software.
• Strong regulatory and document control skills.

Additional Requirements

• The role requires onsite presence at the Deerfield office on Monday, Tuesday, and Thursday, with remote work on Wednesday and Friday.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

Required Employment / Compliance Language

Medix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type regardless of minor attributes or basis statuses.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.