Responsibilities
- The Quality Assurance Manager is responsible for providing leadership and oversight for several quality management systems including oversight of CAPA program, investigating product complaints, executing both supplier and internal cGMP audits, and trending.
- Preparation of revenue and Capex budget as per spent analysis project. Maintain quality system controls to ensure no critical and major market complaints.
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
- Take appropriate steps to reduce wastage and losses in the analysis process and build improved efficiency.
- Develops Standard Operating Procedures (SOPs) governing Quality Management Systems.
- Implements process flows that ensure on-time closure of records and projects.
- Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
- Relocation provided, regional candidates preferred. $90K-$120K.
Requirements
- The Quality Assurance Manager will have a BS degree with a scientific major or similar.
- 5+ years of pharmaceutical & FDA/GMP industry experience is required. At least 3 years in a management capacity.
- Ability to implement and oversee cGMP Quality systems.
- Experience managing personnel, including goal setting and performance reviews.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.