CAPA Manager

Simtra US LLC; Bloomington (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a CAPA Manager to lead the Corrective and Preventive Action (CAPA) quality system and ensure compliance with regulatory requirements. You will oversee investigations, root cause analysis, and the implementation of effective CAPA actions across the organization.

Collaborating with cross‑functional teams, you will train deviation authors and CAPA owners, trend CAPA metrics, and present findings to management and during regulatory

Qualifications

• Bachelor’s degree in a science-related field with 5+ years pharma/medical device experience or Master’s with 3 years.
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Experience managing CAPA systems and investigations.
• Ability to analyze quality data, trends, and identify systemic issues using analytical tools.
• Familiarity with electronic quality management systems (Veeva, TrackWise) and Microsoft Office; data visualization (Power BI) a plus.

Responsibilities

• Serve as CAPA Program Owner, ensuring regulatory compliance.
• Oversee daily CAPA quality system operations and timely closure of CAPAs.
• Lead investigations for deviations.
• Apply structured problem-solving tools (5 Whys, Fishbone, FMEA) to identify root causes and implement CAPA actions.
• Review and approve CAPA documentation for completeness and accuracy.
• Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary.
• Train deviation authors, CAPA and CI owners to ensure competency in investigation/documentation.
• Trend CAPA metrics and perform root cause analysis on system performance to identify issues.
• Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
• Provide training and guidance on CAPA processes.
• Support internal, client, and regulatory audits related to CAPA activities.
• Partner with Manufacturing, Technical Services, Quality, and Engineering to ensure timely CAPA resolution.

Skills

CAPA management

Investigations

Data analysis

cGMP knowledge

Quality metrics

Education

Bachelor's degree in science or related field

Master’s degree in related field

Tools

Veeva

TrackWise

Excel

Power BI

Job description

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?

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.

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 (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:

• Bachelor’s degree required, preferably in a science‑related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s 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 (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, 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
• 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.

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