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Manager Document Control and Training
Company: Civica
Location: Petersburg, Virginia, VA
Employment Type: Full Time
Date Posted: 11/07/2024
Expire Date: 01/07/2025
Job Categories: Medical
Job Description
Manager Document Control and Training
The Quality Document Control and Training Manager will join the Civica, Inc. (“Civica”) organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

The role is essential to assure the Petersburg site’s document control and training management system complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. This role is responsible for leading the quality document control and training team and developing quality systems and processes to enable the manufacture of sterile injectable medications.

Essential Duties and Responsibilities:

Manages and oversees day to day activities associated with document control, records retention, batch record management and training.
Working across functions, 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.
Responsible for 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 and/or present at routine Quality Council meetings.
Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
Manages and develops 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.
Participates in activities to support regulatory agency inspections.
Travel limited but may occasionally be required.
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
Contact Information
Company Name: Civica
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