Quality Manager I, Data Integrity

Job Description

Simtra BioPharma Solutions is seeking a Quality Manager I, Data Integrity to provide oversight for site data integrity compliance and improvement initiatives. The Quality Manager will establish and maintain site KPI and metrics reporting processes, reporting to the Quality Manager II.Responsibilities include:

• Leading a cross-functional team in the planning, developing, and conducting of assessments and remediation action plans for Data Integrity.
• Reporting on facility weaknesses and recommending corrective actions.
• Evaluating corrective and preventive action responses to data integrity audit findings.
• Identifying and closing gaps related to data integrity, validation, and corporate procedures.
• Supporting GMP and Pre-Approval Inspection audits, interfacing with regulatory inspectors and driving quality risk remediation activities.
• Authoring, reviewing, and approving documentation as required.
• Supporting the development and monitoring of metrics for site quality systems.
• Providing guidance and technical expertise in interpreting regulatory requirements.

Desired qualifications include:

• Bachelor's degree in a scientific or technical discipline.
• 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.
• Computer proficiency in Microsoft Word, Excel, and Outlook.

Simtra BioPharma Solutions offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program