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 Director of Quality responsible for overseeing quality operations in an FDA-regulated sterile drug manufacturing facility. The primary responsibilities include ensuring compliance with FDA 503B guidance, USP standards, and facilitating audits and inspections.
Key Responsibilities
- Serve as the Subject Matter Expert (SME) for parenteral drug manufacturing in an aseptic environment.
- Ensure quality activities align with FDA 503B guidance, USP 797, and USP 800.
- Lead management during regulatory inspections and audits.
- Oversee quality control processes for the sterile drug manufacturing facility.
- Manage documentation and review of batch records for compounded sterile products.
- Handle quality system management including CAPA program, change control, and product recalls.
- Review and approve validation protocols and SOPs.
- Maintain compliance with Wholesale Drug Distribution requirements.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related discipline; M.S., Pharm.D., or MBA preferred.
- Minimum 8+ years of experience in aseptic processing of sterile drugs for human use.
- Minimum 5+ years in a leadership capacity.
- Expert-level knowledge of Section 503B and FDA guidance documents.
- Familiarity with USP 797 and 800 standards, USP 71 Sterility Tests, and state regulations.
- Proficiency in cGMP for sterile drug manufacturing.
- Success leading FDA inspections and external audits.
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 will comply with all federal and state requirements for employment. Medix provides equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, or veteran status.
*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.
