Quality Assurance Director
3 days ago
We are seeking an experienced Quality Assurance Director to join our Quality & Compliance team at Catalent Inc. The successful candidate will play a crucial role in ensuring compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements.
Responsibilities:
The Quality Assurance Director will be responsible for executing internal audits, facilitating customer audits, maintaining facility licenses and registrations, organizing documentation and facilitating review in support of client regulatory submissions, monitoring and assessing changes to regulatory guidance and compendial monographs, supporting and enhancing the effectiveness of the quality system, driving alignment and improvement initiatives, overseeing customer Quality Agreements, drafting and executing technical plans, protocols, control strategies, and reports related to process validation and process monitoring, and maintaining statistical tools to meet requirements for system and process monitoring and review.
Requirements:
- Doctorate Degree in STEM discipline with minimum of 6 years related experience OR Master's Degree in STEM discipline with minimum of 8 years related experience OR Bachelor's Degree in STEM discipline with minimum of 10 years related experience OR Associate's Degree in STEM discipline with minimum of 14 years related experience
- Ability to see and hear and read and write clear English and to use Excel, Word, and other office systems
- Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines
- Ability to communicate effectively and follow/retain detailed written and verbal instructions in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, professionally and accurately
- Ability to independently lead investigations, deviations, and change controls and to problem-solve and initiate, develop, and execute corrective action
Benefits:
- $160,000 per year
- 152 hours of paid time off annually + 8 paid holidays
- Medical, dental, and vision benefits effective day one of employment
- Tuition Reimbursement
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