Associate Director, Quality Assurance
2 days ago
Civica Rx is seeking an experienced Associate Director, Quality Assurance - Engineering to join our team at our Petersburg, Virginia site. As a key member of our quality team, you will be responsible for establishing and maintaining quality systems and compliance oversight to ensure the validation/qualification and operation of processes, facility, equipment, and computer systems meet cGMP and Civica requirements.
Key Responsibilities- Provide leadership, direction, and support to the people within Quality Assurance Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
- Establish and maintain the site's quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
- Ensure the Quality oversight and review of validation and qualification activities and documentation for the site is performed including assurance that the appropriate resources, materials, and documentation are utilised, and that work is performed in a compliant and controlled manner.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
- Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
- Ensure implementation and quality oversight related to the overall compliance of the facility, utilities, equipment, and manufacturing processes.
- Lead operational and inspection readiness for Health Agency inspections.
- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
- Participate or lead in quality risk analysis/assessments.
- Participate or lead the assessment, qualification, and approval of suppliers.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
- Lead and participate in deviation investigations as necessary.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
- Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.
- Bachelor's degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience including 7 years in a supervisory role in the pharmaceutical industry.
- Experience in facility, utilities and equipment qualification, computer and process validation and calibration and maintenance programs for the manufacture of sterile injectable medications.
- Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operations success including but not limited to Annex 1 requirements for sterile injectable medications, 21CFR Part 11, Electronic Records and Signatures and data integrity.
- Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
- Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
- Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
- Participation and leading activities to support regulatory agency inspections (FDA/EMA) required.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
- Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
- Ability to collaborate and manage conflict in a fast-paced environment.
- Self-motivated, flexible, and able to work in a small, start-up, and dynamic environment.
- Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
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Associate Director, Quality Assurance
2 days ago
Petersburg, United States Civica Rx Full timeAbout the RoleCivica Rx is seeking an experienced Associate Director, Quality Assurance to join our team at our Petersburg, Virginia site. As a key member of our quality assurance operations team, you will be responsible for establishing and maintaining quality systems and compliance oversight of manufacturing operations to ensure medications manufactured...
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