Job Description

About Civica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran\'s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica\'s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica\'s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been \xe2\x80\x9cDo What Is in the Best Interest of Patients.\xe2\x80\x9d Civica\'s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica\'s innovative model is directly impacting patient care, click to read a summary from the New England Journal of Medicine. ( )

To learn more about Civica\'s plans to bring affordable insulin to Americans living with diabetes, click to read an article in BioSpace.

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POSITION SUMMARY

The Senior Manager of Validation will lead, support, and coordinate the work of the Validation team to ensure facilities, utilities, equipment and processes are qualified, maintained and calibrated properly on schedule complying to appropriate guidelines / specifications and internal procedures. The Civica Petersburg facility, nearing substantially complete construction, will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines. We are seeking an exceptional leader who thrives in a fast-paced environment to oversee our Validation group. As the Senior Manager of Validation, 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

• 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 cleaning & 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.
• Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).
• 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.

BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• A minimum of a bachelor\'s degree is required. An advanced degree, such as an MBA, is desired.
• 10+ year\'s progressive experience in 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.
• Ability to manage teams of varying education levels and cultural backgrounds to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Willingness to adapt to changing priorities as project demands change.
• Ability to explain complex technical issues to external customers / agencies.

PREFERRED QUALIFICATIONS

• SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Demonstrated management and delivery of large capital projects.
• Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.

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