Quality Manager I Data Integrity
Quality Manager I Data Integrity
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1 Vacancy
Job Description
Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 daytoday 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 crossfunctional team in the planning developing and conducting of assessments and remediation action plans for Data Integrity. Reports on facilitys 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 PreApproval 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:
- Bachelors 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 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
- Short and LongTerm 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
- Voluntary Insurance Benefits
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.
EEO is the Law
EEO is the law Poster Supplement
Pay Transparency Policy
Data Privacy
To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy:
Manager
Employment Type
Full Time
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