Director, Product Quality
Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Job Description:54 people have viewed this job
Kite is seeking a Product Quality Director for Kite’s Commercial programs.In this role, you will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. Commercial programs encompass programs starting at commercial site transfer through lifecycle management.You will also be responsible for overseeing a group of cross-functional personnel to ensure all aspects of phase appropriate activities are managed and will work with management regarding operational/organizational strategy and have responsibility for providing technical input for late-stage and commercial regulatory files, comparability studies, RTQs, specifications and PQ operational strategies.
As a product expert in Quality, you will be responsible for working directly with Operations Leaders, International Expansion (IE), Quality Control (QC), corporate Quality, Regulatory, Process Development (PD), Quality Assurance (QA), etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to product(s).
Other responsibilities included (but are not limited to):
Provide strategic and operational direction on behalf of Product Quality to Commercial programs through strong scientific leadership related to global regulatory filing strategies, analytical comparability and specifications.
Exhibit the capacity to communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
Write and review appropriate sections of BLA filings.
Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
Exhibit an ability to work and navigate within an evolving scientific and regulatory environment.
Skills / Qualifications:
B.S. in biochemistry, biology, or a related protein/biotechnology sciences field and 10 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environment
Advanced degree in biochemistry, biology, or a related protein/biotechnology sciences field and 8+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience.
10+ years working in a regulated environment (either direct GMP or technical support)
5 + years’ experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation.
5 + years’ experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of biopharmaceutical product commercialization and life cycle management.
Strong preference for familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions.
Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful.
Knowledge of analytical techniques used for biologics product quality control with a particular preference for experience in analytical comparability assessments to support manufacturing changes.
Understanding of cell therapy and drug product development and manufacturing.
In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.
Previous experience working on a cross-functional team in a matrix environment is a plus.
Excellent written and verbal communication skills, including facilitation and presentation skills are important