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Quality Document Control and Training Manager

2 months ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure the consistent availability of affordable medicines for patients.

We are a collaborative organization, working with health systems and philanthropies to develop and manufacture essential generic sterile injectable medications. Our team of experienced healthcare and pharmaceutical industry leaders is committed to delivering high-quality results and working with others to overcome challenges.

Job Description:

**Quality Document Control and Training Manager**

We are seeking a highly skilled Quality Document Control and Training Manager to join our team at the Petersburg, Virginia site. This role is essential to ensuring the site's document control and training management system complies with applicable regulatory standards and expectations for the development and reliable supply of quality medicines.

The successful candidate will have a strong background in quality system management, with experience in managing document control, records retention, batch record management, and training. They will be responsible for leading the quality document control and training team and developing quality systems and processes to enable the manufacture of sterile injectable medications.

**Key Responsibilities:**

  • Manage and oversee day-to-day activities associated with document control, records retention, batch record management, and training.
  • Lead the establishment and maintenance of the site's quality system framework, including quality systems related to document control, batch record issuance and control, and training.
  • Develop and/or improve quality processes and systems.
  • Oversight of Document controls and training management system at the Petersburg site.
  • Track, trend, and analyze quality system data and information for the site. Summarize findings and recommendations for management and team awareness.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Manage and develop personnel.
  • Promote a quality mindset and quality excellence approach to all activities.
  • Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
  • Maintain current knowledge of FDA and Civica requirements to keep pace with evolving regulations and requirements.
  • Participate in activities to support regulatory agency inspections.

**Basic Qualifications and Capabilities:**

  • 8 years' experience in pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Quality system management experience.
  • Minimum of 3 years' experience in a supervisory role.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share knowledge with others.

**Preferred Qualifications:**

Experience in Veeva Quality Management Systems