Job Description
Job Description: Lead the QC Shared Projects team to support manufacture, testing and release of Drug Substance and Sterile Drug Product. Achieve quality objectives, deliver continuous improvement, and ensure audit readiness. Develop training programs and foster strong relationships within the biologics quality network. Prioritize safety, motivate staff, and support QC planning. Bachelor's or Master's degree in Science or related field required, with a minimum of 6 years' experience in the Pharmaceutical Industry. Proven leadership, communication, and project management skills necessary. Demonstrated knowledge of GMP, GDP, and US and EMA regulations. Profit from working with a company that encourages excellence, innovation, and diversity. Enjoy a competitive salary, great benefits package, and annual bonus. Help patients fight serious diseases and be part of a team that makes a difference.
Key Responsibilities:
Leadership of QC Shared Projects team
Site Trending Program for Quality Control
Delivering QC Project portfolio
Continuous improvement initiatives
Technical training structure and program
Ensuring audit readiness
Ensuring compliance with company policies and directives
Building relationships within the biologics quality network
Coaching and developing staff
Prioritizing safety and leading by example
Qualifications & Experience:
Bachelor/Masters in Science or related discipline
6 years' experience in the Pharmaceutical Industry
Deep understanding of GMP/GDP principles
Proven leadership and people management skills
Experience interacting with regulatory agencies
Knowledge of US and EMA GMP regulations
Demonstrated leadership, communication, and project management skills