Associate Director, Validation
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description

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

Essential Duties and Responsibilities:

• Develop the validation strategy for the site and maintain the Validation Master Plan.
• As a member of the site leadership team contributed to the strategic initiatives and operational plans for the site.
• Implement validation policies and related procedures based on regulations and industry standards.
• Oversee 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 validation programs. Plan validation efforts using a risk-based approach.
• Provide oversight and direction to Aseptic Processing Simulation (APS) and Air Visualization Studies.
• Lead Change Control activities and support Tech Transfers to ensure validation activities are identified to support new and existing products.
• Mentor, coach, train and develop validation staff.
• Provide training on validation policies, procedures and requirements.
• 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.
• 7+ years of subject matter expertise with validation execution.
• 3+ 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.
• Experience with CQV, cleaning validation and aseptic process simulations.
• Ability to manage diverse teams to execute on the floor activities such as SAT, FAT, IQ/OQ/PQ, CIP, SIP as well as Engineering and PPQ batches.
• Subject matter expertise with Data Integrity.
• Excellent oral and written communication skills, including presentations.
• Ability to explain complex technical issues to key stakeholders and regulatory agencies.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• 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 process validation and 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.