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Quality Site Head

San Jose, CA

Order: 53032

DIRECT HIRE OPPORTUNITY

 

Are you looking to apply your 503B Quality Management experience in a position with equal reward and opportunity?

 

Do you want to partner with a company that takes pride in its’ workplace environment, actively seeks out and applies constructive feedback to better SOP’s and provides excellent benefits to its’ employees?

 

We are in immediate need of a Director of Quality/Quality Site Head to oversee all Quality Control activities for a pharmaceutical manufacturing facility. The position is responsible for managing a team of 12 that are responsible for assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an expert understanding of cGMP requirements- and experience in day to day operation of a sterile, injectable environment. The position requires an individual who works well both independently and in a team environment, who has experience with successful FDA audits, who has strong aseptic processing background from a quality perspective, someone able to get involved in both QA and QC activities and bettering their processes and someone who has an eye for future improvements, overall operations plans and team development.

 

Qualifications:

 

  • Minimum 5 years of Supervisory experience of a Quality Department in an aseptic manufacturing environment or commercial compounding facility

  • Bachelor’s Degree (in a scientific discipline desired)

  • Knowledge and experience in Quality Assurance/Quality Control in a compounding facility

  • Knowledge of compounding techniques, controlled environments, and compounding facilities

  • Strong Microsoft Applications skills: Excel, Word, Outlook and statistical analysis understanding

  • Ability to train team members

 

Qualified candidates please email your resume to lramirez@suna.com