Quality Assurance - Engineering Manager
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.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a recent article from the New England Journal Of Medicine.
The Quality Assurance-Engineering Manager 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 quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building 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 validation and qualification programs complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) 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 provide quality oversight of validation, qualification and ongoing operation activities of facility, utilities, process, equipment, instrumentation and to ensure FDA requirements are met.
Essential Duties and Responsibilities:
- Working across functions, to ensuring the site's quality system processes related to GMP compliance of the facility, equipment, computer systems and processes.
- Ensure the Quality oversight and review of validation and qualification activities for the site is performed including assurance that the appropriate resources, materials, and documentation are utilized, and that work is performed in a compliant and controlled manner.
- Maintain current knowledge of regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
- Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
- Ensure implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
- Support quality processes and systems across the facility, equipment and product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, data integrity, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
- Participate or lead in quality risk analysis.
- Participate or lead the assessment, qualification, and approval of suppliers.
- Provide leadership, direction, and support to the people within the Quality Assurance Engineering department and ensure that they are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
- Travel (up to 10%) may be required.
Basic Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in facility, utilities and equipment qualification, computer and process validation, calibration and maintenance and data integrity is required.
- Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
- Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
- Participation and leading activities to support regulatory agency inspections required.
- Minimum of 3 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.
- Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.