Current Statistics
1,478,750 Total Jobs 359,980 Jobs Today 16,847 Cities 222,692 Job Seekers 146,721 Resumes |
|
|
|
|
|
|
Director, Quality Systems - Severn Maryland
Company: Disability Solutions Location: Severn, Maryland
Posted On: 04/21/2024
POSITION SUMMARY The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, supplier quality, audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed.The Role - Provides strategic direction to the QA Systems staff supporting Investigation/Deviation/ CAPA Management, Change Control, Risk Management, Quality Metric Tracking responsibilities
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines----
- Build effective teams that apply their diverse skills and perspectives to achieve common goals. Drive engagement and create a culture where employees are motivated to do their best
- Oversee daily activity for the group to ensure quality results Performance management for direct reports.
- Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
- Responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments
- Perform trending reviews of deviations and investigations, compile reports and identify trends or areas requiring additional actions
- Responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls
- Responsible for and administers the Risk management system and track completion of risk assessments
- Compile pertinent QA metrics for Senior Management review
- Assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items for completion
- Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials
- Work with clients during initial and subsequent manufacturing campaigns
- Maintain databases and systems used for tracking various GMP manufacturing associated support activities
- Assists with the generation and/or revision of GMP documentation such as standard operating procedures
- Manages regulatory (FDA, EMA) and client audits/inspections of Catalent. Responsible --performing internal audits
- Work closely with other departments at Catalent and offer assistance as needed
- Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standardsThe Candidate
- Bachelor's degree with 12-14 years or Masters' degree with 10-12 years in a Scientific, Engineering or Biotech field within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation.
- 6 - 8 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.--
- ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
- Expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus
- Proficient with electronic systems, including developing and producing reports.
- Experience with data analytics and concepts
- Ability to quickly learn and navigate new electronic systems
- Able to work in a team setting and independently under minimum supervision
- Ability to work in fast paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
- Creative individual with excellent trouble shooting skills
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.Why You Should Join Catalent
|
|
|
|
|
|
|