CAPA Manager
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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 teamsso we can solve problems in new ways.
Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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.
This role:
The CAPA Manager is responsible for leading and managing the Corrective and Preventive Action (CAPA) Quality System to ensure compliance with corporate client and regulatory requirements. This role oversees investigations root cause analysis and implementation of effective corrective and preventive actions across the organization. The CAPA Manager collaborates with cross-functional teams and serves as a key point of contact for CAPA-related activities. This position reports to the Sr. Manager Quality.
The responsibilities:
- Serve as the CAPA Program Owner ensuring compliance with corporate and regulatory guidelines.
- Oversee day-to-day operation of the CAPA Quality System including recurring CAPA meetings and timely closure of CAPAs.
- Lead and facilitate investigations for deviations.
- Utilize structured problem-solving tools (e.g. 5 Whys Fishbone FMEA) to identify root causes and implement effective corrective/preventive actions.
- Review and approve CAPA documentation for completeness and accuracy.
- Escalate quality issues to Sr. Manager Quality or Quality Director as necessary.
- Train and qualify deviation authors CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes.
- Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
- Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
- Provide training and guidance to personnel on CAPA processes and best practices.
- Support internal client and regulatory audits related to CAPA activities.
- Partner with Manufacturing Technical Services Quality functions and Engineering to ensure alignment and timely resolution of CAPA actions.
- Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.
The qualifications:
- Bachelors degree required preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience including management experience OR masters degree with 3 years of pharmaceutical or medical device industry experience
- Strong knowledge of cGMP FDA EMA and ICH guidelines.
- Proven experience managing CAPA systems and leading investigations.
- Demonstrated ability to analyze and interpret quality data trend metrics and identify systemic issues using analytical tools.
- Familiarity with electronic quality management systems (e.g. Veeva TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g. Excel advanced functions Power BI) is a plus.
Physical / safety requirements:
- Duties may require overtime work including nights and weekends.
- Position may require sitting or standing for long periods of time.
In return youll be eligible for1:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life 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
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- 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
1 Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:
Manager
Key Skills
About Company
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