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Director Biologics Quality
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Director Biologics Quality
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BioSpace
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 created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, have joined Civica. Civica has supplied medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, operating in 49 states.
Civica’s mission extends beyond hospitals to consumers via CivicaScript, making affordable, quality outpatient generic medicines. The company partners with manufacturers and payors to develop and distribute cost-effective medicines, including biosimilars like insulin.
Our new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables and biosimilar insulins, ensuring access and affordability for all Americans.
The Civica Foundation supports philanthropic efforts, notably to bring affordable insulin nationwide. Civica champions a movement prioritizing patient needs over profits.
Learn more at
www.civicarx.org
Job Description
The Director of Biologics Quality is a motivated leader with expertise in quality assurance, overseeing activities across partners, focusing on biologic processes, product development, and regulatory compliance. Based at our Virginia facility, this role involves managing drug substance manufacturing, analytical assessments, validation, and regulatory interactions, reporting to the Vice President of Quality.
Essential Duties And Responsibilities
Provide technical quality support for internal and external teams.
Ensure process robustness and reliability.
Oversee validation of analytical methods and processes.
Review and approve manufacturing documentation and quality records.
Assess and validate analytical methods for biosimilarity.
Review regulatory filings for insulin analogs.
Make decisions on validation/qualification of biosimilars and escalate issues.
Manage drug substance disposition and readiness for regulatory filings.
Ensure compliance with GMP, regulatory standards, and company policies.
Represent QA during inspections and audits.
Oversee staff training and development.
Collaborate across departments to improve product/process robustness.
This description is not exhaustive and duties may vary.
Basic Qualifications And Capabilities
Extensive experience in pharma or biotech industries.
Proven quality oversight experience.
Knowledge of GMP regulations and validation processes.
Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, Engineering, or related field.
Hands-on GMP operations oversight experience.
Experience with validation strategies and audits.
Data synthesis and stakeholder communication skills.
Ability to work collaboratively in a fast-paced environment.
Excellent communication skills.
Physical Demands And Work Environment
Travel up to 50% domestically and internationally for oversight and site visits.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Internet News
#J-18808-Ljbffr
Director Biologics Quality
role at
BioSpace
1 week ago Be among the first 25 applicants
Join to apply for the
Director Biologics Quality
role at
BioSpace
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 created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, have joined Civica. Civica has supplied medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, operating in 49 states.
Civica’s mission extends beyond hospitals to consumers via CivicaScript, making affordable, quality outpatient generic medicines. The company partners with manufacturers and payors to develop and distribute cost-effective medicines, including biosimilars like insulin.
Our new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables and biosimilar insulins, ensuring access and affordability for all Americans.
The Civica Foundation supports philanthropic efforts, notably to bring affordable insulin nationwide. Civica champions a movement prioritizing patient needs over profits.
Learn more at
www.civicarx.org
Job Description
The Director of Biologics Quality is a motivated leader with expertise in quality assurance, overseeing activities across partners, focusing on biologic processes, product development, and regulatory compliance. Based at our Virginia facility, this role involves managing drug substance manufacturing, analytical assessments, validation, and regulatory interactions, reporting to the Vice President of Quality.
Essential Duties And Responsibilities
Provide technical quality support for internal and external teams.
Ensure process robustness and reliability.
Oversee validation of analytical methods and processes.
Review and approve manufacturing documentation and quality records.
Assess and validate analytical methods for biosimilarity.
Review regulatory filings for insulin analogs.
Make decisions on validation/qualification of biosimilars and escalate issues.
Manage drug substance disposition and readiness for regulatory filings.
Ensure compliance with GMP, regulatory standards, and company policies.
Represent QA during inspections and audits.
Oversee staff training and development.
Collaborate across departments to improve product/process robustness.
This description is not exhaustive and duties may vary.
Basic Qualifications And Capabilities
Extensive experience in pharma or biotech industries.
Proven quality oversight experience.
Knowledge of GMP regulations and validation processes.
Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, Engineering, or related field.
Hands-on GMP operations oversight experience.
Experience with validation strategies and audits.
Data synthesis and stakeholder communication skills.
Ability to work collaboratively in a fast-paced environment.
Excellent communication skills.
Physical Demands And Work Environment
Travel up to 50% domestically and internationally for oversight and site visits.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Internet News
#J-18808-Ljbffr