Associate Director Quality Operations
2 days ago
We are seeking a highly motivated Associate Director, Quality Operations to manage and coordinate the new PA facility's Quality Operations team. The Quality Operations team will be responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures.
Key Responsibilities:- Lead the Quality Operations team, ensuring daily support for all manufacturing
- Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management
- Review batch records and related production documentation, ensuring resolution of all identified issues prior product release
- Disposition incoming raw materials
- Final product release
- Issuance of batch records and labels
- Assist with investigation of manufacturing deviations, OOS results, temperature excursions and other non-conformances
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope
- Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
- Initiate and participate in standard operating procedure (SOP) revisions to improve quality metrics
- Bachelor's Degree in Science, Engineering, or a related technical discipline
- At least 8 years of experience in the pharmaceutical industry in an aseptic manufacturing environment
- Knowledge of cGMP regulations
- Skilled in use of Microsoft Word, Excel, and PowerPoint
- Familiarity with QMS systems
- Supervisory experience is a plus
- This position will work in both an office and a manufacturing lab setting
- When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach
- Able to work in a cleanroom with biohazards, human blood components, and chemicals
- Potential exposure to noise and equipment hazards and strong odors
Iovance Biotherapeutics Inc is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
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