Sr. Program Manager Microbiological Quality and Sterility Assurance

---

Job description

WHY CIVICA?

Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica's mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.

Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.

WHO CIVICA SERVES

While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and "340B" hospitals caring for vulnerable patients in some of the country's most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.

With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023. As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.

Commentary: The Health Care Utility Model: A Novel Approach to Doing Business

Job Description

The Senior Program Manager Microbiological Quality and Sterility Assurance 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 establishing and maintaining the environmental control program and microbiology testing laboratory from onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The role is essential to assure the Petersburg site's environmental control and microbiology sterility assurance programs comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to support the design, implementation, and maintenance of a robust environmental control system and microbiology laboratory that meets or exceeds FDA requirements.

Essential Duties and Responsibilities:

• Working across functions, lead the Environmental Monitoring (EM) and sterility assurance programs to enable the reliable supply of quality generic medications to patients.
• Design and establish microbiological testing laboratory.
• Develop and lead EM/microbiology/sterility assurance related quality systems activities including, but not limited to, aseptic process simulations (i.e., media fills) and environmental monitoring risk assessments and control plans, facility, utility, and isolator filling line qualifications, change control, CAPA, deviations and investigations.
• Develop and/or improve environmental control processes and systems.
• Develop programs and educate personnel on the importance of microbiological control.
• Identify, track and facilitate resolution of technical issues.
• Track, trend, and analyze EM and microbiology testing data for the site. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
• Participate or lead the assessment, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead and maintain aseptic training program and sterility assurance risk assessments.
• Author and/or review and approve SOPs, protocols, reports and test method documents as applicable.
• Promote a quality mindset and quality excellence approach to all activities.
• Travel (up to 10%) may be required.

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in sterile injectable manufacturing, aseptic processing and facility qualification.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Microbiology testing and environmental monitoring management experience across the product development and commercialization lifecycle including facility and utility qualification and ongoing monitoring in assuring a state of microbiological control.
• Participation and leading activities to support regulatory agency inspections required.
• Minimum of 2 years' experience in a supervisory role highly desired.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• 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.

Preferred Qualifications:

Technical expertise in pharmaceutical and combination product process and isolator technology highly desirable.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

PI