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 compliance oversight to ensure the facility, utilities, 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 comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. 

Essential Duties and Responsibilities:

·     Working across functions, to establish the site’s quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems.

·     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 utilised, and that work is performed in a compliant and controlled manner.

·     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.

·     Maintain current knowledge of local and international 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 other manufacturing sites.

·     Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, 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.

·     Manage the quality risk management process. 

·     Support as needed process, method and cleaning validation.

·     Proactively identify and work collaboratively to resolve problems by 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 10 years Quality/CGMP management experience in the pharmaceutical industry. Experience in facility, utilities and equipment qualification, computer validation and calibration and maintenance programs.

Knowledge in 21CFR Part 11, Electronic Records and Signatures 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.

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 sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.

Process, method and cleaning validation.

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.