Quality Systems Specialist II
2 months ago
About Civica
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description:
The Quality Systems Specialist II for Data Integrity will join the Civica, Inc. ("Civica") organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities of the position include oversight of Civica Petersburg Site's data governance program and ensuring appropriate data integrity controls are in place to protect data throughout the data lifecycle. The role is essential to assure the Petersburg site's data governance program complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines.
Essential Duties and Responsibilities:
- Responsible for maintaining data governance program, including design (i.e., establishment of data process flows, assignment of risk rankings, identification of required controls), operation support (e.g., business process/GXP computerized system data integrity issue investigation), and monitoring.
- Provide mentorship and advice on approved procedures, standardization and requirements associated with the quality management system (QMS) and data integrity, including ALCOA+.
- Lead data integrity investigations and work cross functionally to determine root cause and CAPAs.
- Support audit trail reviews.
- Analyze metrics to measure the effectiveness of the data governance program.
- Subject Matter Expert and Key User supporting data integrity and good documentation practices (GDocP).
- Identify and raise data integrity compliance gaps across the quality system.
- Develop and deliver training to new staff on data integrity and other processes and procedures.
- Support audits (internal, regulatory).
- Support inspection readiness activities.
- Promote a culture of quality and drive enthusiasm for data integrity compliance.
- Execute critical initiatives to improve the quality system and data integrity.
- Perform other duties as required.
Basic Qualifications and Capabilities:
- Bachelor's degree with 6+ years of combined technical experience in a GMP related field within a pharmaceutical/biologics manufacturing facility.
- Experience with Quality systems and demonstrated working knowledge in areas such as data integrity, change control, deviation, CAPA, Management Review.
- Demonstrated experience leading and writing investigations.
- Ability to lead risk assessments and root cause analysis.
- Experience with cGMPs and Quality System regulatory requirements.
- Experience with Quality computerized system applications (e.g., Veeva)
- Works on multiple assignments in collaboration with various department system owners.
- Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
- Ability to communicate and work independently with scientific/technical personnel.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Strong organization, and execution skills with an attention to detail.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share knowledge with others. Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
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