- Establish robust operational readiness plans to transition to full-scale production
- Lead the execution of a project quality plan with audit readiness
- Oversee hiring, training, and development of a Quality Operations team
- Develop and implement operational and quality systems
- Collaborate with cross-functional teams and drive decisions
- Provide expert guidance and manage interfaces with business stakeholders
- Lead risk management activities and ensure safety guidelines adherence
- Establish KPIs to measure and report on operational performance
- Drive continuous improvement initiatives for operational efficiency
- Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related field
- Minimum 8 years of experience in aseptic drug product manufacturing, with at least 3 years in a leadership role
- Problem-solving mindset with a commitment to quality and safety
- In-depth knowledge of cGMP regulations and cleanroom operations
- Strong leadership, project management, and communication skills
- Ability to work cross-functionally and manage complex projects
- Proven track record of successful facility start-ups within the pharmaceutical industry
- Experience with budget management and cost optimization in manufacturing
- Desire to contribute to a high-growth, transformational company
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Associate Director, QA Operations, Drug Product - Norwood, United States - Moderna
Description
Job Title: Associate Director, QA Operations at Moderna
Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is in charge of ensuring the quality and compliance readiness for a cutting-edge Drug Product (Fill Finish) cGMP manufacturing facility.
This role involves guaranteeing operational readiness for the production of both clinical and commercial drug products while following current GxP, corporate, regulatory, and industry standards.
Minimum Qualifications
Preferred Qualifications
If you want to join a team that is revolutionizing medicine, Moderna invites you to be part of their mission.
