Associate Director of Validation
Civica

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 "Do What Is in the Best Interest of Patients." 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 here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

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

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

This position will play an essential role in building the Validation function at the Petersburg, VA manufacturing site. The Associate Director of Validation is responsible for developing and implementing the validation strategy and will lead the Commissioning, Qualification and Validation activities to ensure facilities, utilities, and equipment are qualified based on intended use. We are seeking an exceptional leader who thrives in a fast-paced environment to oversee the Validation group.

Essential Duties and Responsibilities:

• Develop the validation strategy for the site and maintain the Validation Master Plan.
• Implement validation policies and related procedures based on regulations and industry standards.
• Provide oversight in the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, utilities, cleaning, analytical methods and instruments.
• Implement and manage cleaning & process validation programs. Plan validation efforts using a risk-based approach.
• Lead Change Control activities and support Tech Transfers to ensure validation activities are identified to support new and existing products.
• Mentor, coach, train and evaluate a team of validation engineers.
• Train end users on validation policies and requirements to support cGMPs.
• Effectively interact and collaborate with cross-functional departments and vendors to drive validation deliverables.
• Serve as subject matter expert in all aspects of validation.
• Establish and maintain continuous improvement projects.
• Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
• 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.
• Implement and maintain Data Integrity Controls to ensure data is protected throughout the data lifecycle. Maintain Part 11 / Annex 11 compliance.
• Forecasts and adheres to departmental budget, and responsibly manages resources.
• Implement a culture of continuous improvement and ensure the adoption of best practices.
• Ensure safety is integral to all activities.

• A minimum of a bachelor's degree or similar technical degree is required.
• 10+ year's progressive experience in validation or related role in the pharmaceutical industry.
• 5+ years of subject matter expertise with validation execution.
• 2+ years of experience as a primary SME with regulatory inspections.
• Extensive experience working in sterile manufacturing, cleanroom, and cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• Excellent oral and written communication skills, including presentations.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Experience with process validation, cleaning validation and aseptic process simulations.
• Ability to manage diverse teams to execute on the floor activities such as SAT, IQ/OQ/PQ, and Engineering batches.
• Subject matter expertise with Data Integrity. Ability to explain complex technical issues to key stakeholders and regulatory agencies.
• Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment.

• SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator).
• Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Experience with continued process verification.
• Demonstrated management and delivery of large capital projects.
• Subject matter expertise with Computerized Systems Validation (CSV)
• Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup.
• Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.