Director Biologics Quality

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 solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description:

The Director of Biologics Quality is a highly motivated technically knowledgeable leader with proven abilities to direct quality assurance activities across multiple internal and external business partners and will provide expertise in the quality engineering and validation of new product introduction and manufacturing for the Civica insulin team. This is an exciting opportunity to be part of the team developing, manufacturing, and launching insulin biosimilars to patients seeking options for affordable insulin. The Director of Biologics Quality will have oversight of drug substance contract manufacturing, comparative analytical assessment for biosimilarity, process development, technical transfer, and validation of drug product formulation and filling.  The Director Biologics Quality will report to the Vice President Quality and will be part of a dedicated insulin team at our Civica Petersburg, Virginia state of the art formulation and filling facility. This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. 

Essential Duties and Responsibilities:

• Provide Technical Quality support for internal and external teams and projects.
• Assure robustness of process to meet CPPs and CQAs to achieve process reliability
• Oversee analytical methods validation and process validation for insulin analog drug substance and drug product.
• Review and approve procedures, master batch records, or any other documentation to assure successful manufacture of drug substance and drug product.
• Review and approve quality system records including change requests, deviations, and CAPA as necessary.
• Ensure comparative analytical assessment methods are fit for purpose
• Review regulatory filings for insulin analogs
• Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management with a focus on problem solving.
• Disposition of drug substance.
• Pre-filing and pre-approval readiness of drug substance CMO.
• Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations. Working in clinical manufacturing is a plus.
• Represent QA during site health authority inspections, and business forums including site leadership teams.
• Ensure staff training and development.
• Partner and influence other departments and functions throughout the organization, including Operations, site Quality, Regulatory Affairs and Technical Development/Services, etc. to implement ongoing product/process robustness to continuously improve.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Basic Qualifications and Capabilities:

• Extensive experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience within a quality oversight function.
• Comprehensive knowledge of global GMP regulatory requirements for qualification, validation hardware and software.
• Experience in BLA authoring and review with preference given to approved molecules.
• Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, Engineering or a related field.
• Hands-on experience with oversight of GMP operations at drug substance and/or drug product facilities.
• Experience with the presentation of validation strategies and execution to auditors and regulatory agency inspectors.
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
• Ability to collaborate and manage conflict in a fast-paced environment.
• Excellent interpersonal, verbal, and written communication skills.

Physical Demands and Work Environment:

• Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site.  Travel of up to 50% may be required.