Job Requirements
B. Qualifications:
Must have
- B.S. Degree in Pharmacy or Chemistry or related field with 7-10 years experience working in a leading Quality Assurance and Quality Control Managerial roles
- M.S. Degree or higher in Pharmacy or Chemistry is a definite plus
- Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
- Proactive approach and strong critical thinking skills
- Strong collaboration, relationship management, and interpersonal skills
- Excellent written and verbal communication
Nice-to-Have
- Global cGMP Regulatory Agency requirements.
- Knowledge in HSA, DEA, OSHA, ICH guidance and EPA regulations applicable to the pharmaceutical industry
C.Competencies and Behaviors:
- Drive for results: the drive to put energy into achieving results and take actions to exceed goals
- Clear and influential communication skills with the ability to work effectively with both medical and commercial stakeholders
- Planning and prioritizing: ability to identify needs to be done and to develop an appropriate action plan in order to accomplish an objective and to monitor progress against it
- Able to cope with stress and change
- Teamwork and co-operation: the willingness to work co-operatively and supportively with your colleagues. Developing positive, open working relationships in order to solve problems and to achieve business goals