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  • Quality Manager

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    Bloomington, Illinois, United States BAE Systems Full time

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Senior Director of Quality and Process Improvement

2 months ago


Bloomington, United States Simtra BioPharma Solutions Full time

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. The responsibilities: Design, propose and implement Q / tech ops initiatives to improve quality performance Design and implement Advanced Problem-Solving tools designed to improve diagnostic evaluation of Root cause detection. Improve and implement continuous improvement strategies, coaching, and training. Improve and design KPI metrics for Corp and site facilities. (RFT/ Dev rate / CAPA/ COPQ) Evaluate and improve CPV (continuous process verification) process Evaluate and assist with improvements in QMS standardization, Lab productivity, Operational excellence, value-analysis, sustainability. Etc. Develop and set up Communities of Practices in accordance with Corporate objectives. Desirable qualifications: BS or higher in Science related field required. 15 years or greater in the field of operational excellence required. Excellent communication skills Lean Six Sigma Blackbelt certification Experience in running multi-site operational excellence efficiency programs Basic understanding of statistics Business level capacity planning, Analysis, and optimization models Excellent computer based skills in Excel, Minitab, Power Point, ERP , TrackWise , SAP, etc. In return, you’ll be eligible for: Day One Benefits

Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance

Spouse Life Insurance Child Life Insurance

Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program

Paid Holidays Paid Time Off Paid Parental Leave and more

Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program

Additional Benefits

Voluntary Insurance Benefits

Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more

Onsite Campus Amenities

Workout Facility Cafeteria Credit Union

Current benefit offerings are in effect through 12/31/24

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