- Manages relationships with external partners for Quality Assurance needs.
- Liaison between external and internal stakeholders of Quality Assurance and Manufacturing Operations during technology transfer and manufacture of new products.
- Leads, approves documents and/or participates in change controls, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Leads Quality Assurance manufacturing shop floor support to achieve smooth product transfer and ongoing manufacturing.
- Drives product and process changes to improve product quality.
- Reviews and aids in the establishment and maintenance of Quality Agreements Review and Approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures and Technical Transfer Protocols.
- Proactively identifies and works collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Leads or participates in Quality Risk Management and Data Governance Processes as needed.
- Leads pre-approval inspection readiness activities.
- Participates in activities to support regulatory agency inspections.
- Promotes a quality mindset and quality excellence approach to all activities.
- Travel is limited but may occasionally be required.
- 8+ years' experience working directly with manufacturing in the sterile injectable pharmaceutical or medical device industries.
- Bachelor-level or higher education.
- Project management, organization, and execution skills are required.
- Ability to apply technical expertise to solve problems and issues.
- Experience with technology transfers and new product introduction.
- Knowledge of data integrity controls in a manufacturing setting.
- Familiarity with Annex 1 requirements.
- Participating in and leading activities that support regulatory agency inspections is required.
- 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.
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QA Operations Manager - Petersburg, United States - Civica Rx
Description
About Civica
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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Job Description:
The Quality Assurance (QA) Operations Manager will join the Civica, Inc. ("Civica") organization and its newly forming team 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 sterile injectable medications and combination products.
The role is essential to assure the Petersburg site's manufacturing and operations activities comply 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 will also work closely with external partners and the Civica Petersburg Site for Quality Assurance processes and controls ensuring adherence to applicable regulations for transfer and manufacture of sterile injectable drug product.
Essential Duties and Responsibilities:
Basic Qualifications and Capabilities:
