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

Job Summary

The Sr. Director Quality Operations will provide strategic leadership and oversight of quality operations for our client. This role ensures compliance with global regulatory requirements and internal quality standards across the manufacturing, testing, and distribution of radiopharmaceutical products. The Sr. Director, Quality Operations will serve as a key quality leader, partnering cross-functionally to drive a culture of compliance, operational excellence, and continuous improvement.

Key Responsibilities

• Develop and execute the Quality Operations strategy to support radiopharmaceutical manufacturing, testing, and supply chain.
• Serve as Quality leader for commercial and clinical radiopharmaceutical products, ensuring compliance with cGMP and radiation safety standards.
• Perform audits of clients, vendors, manage corrective actions, and host audits and inspections by customers/partners and regulatory agencies.
• Review and approve documentation for the facility, including batch records and investigation reports.
• Prepare regulatory submission data and assist with preparation of the regulatory submission documentation.
• Manage the different Quality departments and ensure compliance with all relevant procedures and directives.
• Design and approve validation processes and completed validation documentation.
• Coordinate with operational departments to ensure alignment with processes and requirements.
• Write, review, and approve SOPs to ensure compliance with Quality and regulatory needs.
• Gather and review Quality exceptions for potential corrective actions and/or system improvements.
• Prepare and host routine reviews of Quality data with senior management.
• Build, mentor, and lead a high-performing Quality Operations team.
• Maintain and continuously improve the Quality Management System.

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 is an Equal Opportunity Employer. Recommend and enable any additional required fields relevant to the job to be filled by the candidate.

^*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.