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.
Intro to Civica
The Validation Manager will lead, support, and coordinate the work of the Validation group to ensure facilities, utilities, equipment and processes are qualified, maintained and calibrated properly on schedule complying to appropriate guidelines / specifications and internal procedures. This role will require the ground-up development of the validation program and provide steering direction for the validation strategy in a Sterile Injectable Facility.
What Will This Person Be Doing?
We are seeking an exceptional leader who thrives in a fast-paced environment to oversee our Validation group. As the Validation Manager, you have the ability to make decisions, and are capable of setting and balancing priorities. You must be able to manage multiple projects with frequent changes and are able to coordinate and manage validation activities while involving cross-functional partners. You have a willingness to perform "hands-on" work in a dynamic, fast-paced work setting. Incumbent provides technical expertise on Manufacturing and Compliance standards and processes to team members; and provides input on strategy to key business leaders.
- Develop and implement validation policies and related procedures based on current regulations and industry standards in support of the company's growth and regulatory requirements.
- Provide oversight in the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, cleaning, analytical methods, instruments, and computerized systems. In some cases, perform, author and review documents.
- Implement and manage cleanign & process validation programs including continued process verification.
- Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
- Train end users on validation policies and requirements to support cGMPs.
- Evaluate all GMP Quality Systems utilizing Risk Assessment approach. Plan validation efforts according to risk.
- Lead Change Control and participate with Tech Transfer activities to ensure validation activities are identified to support new and existing client product and company processes.
- Mentor, coach, train and evaluate a team of junior and senior validation engineers. Lead hiring efforts for team growth and attrition.
- Effectively interact and collaborate with cross-functional departments and vendors in order to meet company expectations.
- Serve as subject matter expert in all aspects of validation.
- Establish and maintain continuous improvement projects in support of company activities and growth.
This Person Will Be Successful If...
- Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.
- Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
- Demonstrates excellent planning and organizational skills, with the ability to balance production and maintenance needs.
- Knowledge of Computerized Systems Validation (CSV) experience and Part 11 compliance; ability to deliver and maintain a compliant validation program.
- Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written. Forecasts and adheres to departmental budget, and responsibly manages cost center resources.
What Is Required
- A minimum of a bachelor’s degree is required. Advanced degree, such as an MBA, is desired.
- 10+ year’s progressive experience in an manufacturing, operations management, or quality role at a pharmaceutical manufacturing / distribution facility, with at least 5 years of subject matter expertise with validation execution, program development or experience.
- A minimum of two years of experience as a primary SME with regulatory inspections is required.
- General knowledge of the pharmaceutical industry, brand and/or generics is preferred.
- Experience working in cGMP environments that meet FDA, EMA, ICH guidelines, local regulations, and industry best practices.
- Experience with regulatory inspections.
- Experience in sterile parenteral manufacturing.
You must be eligible to work in the US to be considered an applicant.