The Director of Quality is responsible for the efficient implementation and adherence to cGMPs as well as the company’s standard operating procedures. The director establishes standards of quality, productivity and performance in accordance with USSF’s policies and procedures and requirements of State and Federal regulatory agencies.
- Advise the management team on regulatory impacts on manufacturing and make
- Ensure compliance with all federal and state laws
- Maintain multi-state certifications as Licensed Pharmacist.
Manufacturing and Process
- Participates in the establishment of operational processes/process improvement
- Coordinates Formulary development and batch production approvals with manufacturing management.
- Ensure quality control of all company output as pertains of all output as pertains to customer acquisitions and delivery of services
- Participates in Batch Record Release for clinical formulations
Management and Administration
- Ensure activities comply with organizational requirements for quality management, legal stipulations and general duty of care
- Reviews and conducts regular audits of internal systems in partnership with quality control team
- Set operational and/or performance goals for each department which are aggressive, achievable and tied to long-term goals.
- Establish and monitor performance reporting systems.
- Conduct regular meetings with department heads to ensure that priorities are clear and coordination is good.
- Ensure quality assurance of all company output as pertains to customer acquisition and delivery of services.
- 2 years working in a pharmaceutical manufacturing environment
- Understanding of change control, CAPAs and risk analysis
- Capable of leading team of individuals
- D. or BS in pharmacy – Current good standing as registered pharmacist in State of Pennsylvania (desired)