Quality Systems Specialist II - Data Integrity (388)
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

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.

• 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.