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:- 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 (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, you'll be eligible for[1]
:- 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
DisclaimerThis 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.
