|Director Biologics Quality|
Location: Petersburg, VA
Employment Type: Full Time
Date Posted: 11/20/2023
Expire Date: 01/20/2024
Job Categories: Healthcare, Other
Director Biologics Quality|
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, 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 product.
Review and approve quality system records including change requests, deviations, and CAPA as necessary.
Provide quality input to new facility design changes as new needs are evaluated.
Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management with a focus on problem solving.
Oversee disposition drug substance.
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.
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.
Bachelorís 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.