Quality Manager I, Data Integrity

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.

This role:

The Quality Manager I, Data Integrity provides oversight for site Data Integrity compliance and improvement initiatives; and is responsible for establishing and maintaining site KPI and metrics reporting processes. This position reports to the Quality Manager II.

The responsibilities:

• Leads a cross-functional team in the planning, developing, and conducting of assessments and remediation action plans for Data Integrity. Reports on facility's weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Evaluates corrective and preventive action responses to data integrity audit or assessment findings for adequacy, including root cause and timeliness.
• Identifies and closes gaps related to data integrity, validation, and corporate procedures. Supports routine GMP and Pre-Approval Inspection regulatory, client, and internal audits. Interfaces with regulatory inspectors during audits as required.
• Leads and drives completion of Quality risk remediation activities.
• Author, review, and/or approve documentation as required.
• Supports the development and monitoring of appropriate metrics for site quality systems, projects, and improvement initiatives. Reports data to management when required for internal metrics.
• Provides guidance and technical expertise in interpreting regulatory and Simtra requirements in quality strategy and processes.

Desired qualifications:

• Bachelor's degree required, in a scientific or technical discipline preferred.
• Minimum 5 years experience with data integrity in the pharmaceutical/biotech industry.
• Thorough knowledge of worldwide regulatory agency regulations for Documentation and Data Integrity.
• Project Management skills preferred.
• Experience with computer system validation and data integrity principles required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, TCU, Veeva, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to gown qualify for Grade C and D production areas
• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long hours.

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
  • 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

[1] Current benefit offerings are in effect through 12/31/24

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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