Quality Assurance-Operations Manager

Employer
Civica Rx
Location
Petersburg, Virginia
Posted
Sep 24, 2021
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

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.

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

Job Description


The Quality Assurance - Operations 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 and compliance processes associated with sterile manufacturing and operations from the 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 manufacturing and operations activities 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. Responsibilities also include, but are not limited to, shop floor oversight and the generation, review and/or approval of policies, procedures, reports, batch records and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements.

Essential Duties and Responsibilities:
  • Working across functions, lead the establishment and maintenance of the site's quality systems related to manufacturing operations and packaging to enable the development and reliable supply of Civica generic medications to patients.
  • Responsible for all operational compliance aspects of sterile fill finish manufacturing of products including but not limited to: batch record review, batch disposition, and shop-floor quality.
  • Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products at the site comply with Civica and relevant cGMP regulatory requirements.
  • Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP through QA shop-floor support.
  • Provide leadership, direction, and support to the people within the Quality Assurance Operations 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 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.
  • Responsible for ensuring raw materials, excipients, APIs and components are qualified and their suppliers are approved in accordance with Civica and GMP requirements.
  • Responsible for ensuring that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labelling and drug products are released in accordance with the registered specifications.
  • Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
  • 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.
  • Participate or lead in quality risk analysis.
  • 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 sterile injectable manufacturing and packaging operations is required.
  • Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Quality assurance 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.
Preferred Qualifications:
  • Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is 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.



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