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Associate Director, Validation (243)

Employer
Civica Rx
Location
Petersburg, VA
Start date
Feb 3, 2025
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Job Details

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more 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. 

Basic Qualifications and Capabilities:

  • 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. 

Preferred Qualifications:

  • 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.


Company

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. 
 
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 available by 2023.   

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Company info
Website
Location
1 Civica Way
Petersburg
VA
23805
United States

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