Overview:
Reporting to the Director of QA and Compliance, the Quality Assurance Manager will act as site representative for quality systems and ensure that all QA functions are compliant with GMP and CGP regulations and consistent with company policies and procedures in addition to conducting audits that insure continuous control over materials, products, and vendors throughout the production cycle.
The QA Manager will own the Satsuma Pharmaceuticals Document Control system and will be the process owner for development of controlled documents including – policies, procedures (SOPs), and work instructions across the Satsuma organization. They will remain current on industry trends and best practices for development/deployment of quality assurance methodologies and solutions for the organization.
Responsibilities Include:
- Oversees Document Control efforts including import of documents for vendor qualifications and organization an assembly of documents for regulatory filings.
- System owner for controlled document creation, revision, and obsolescence.
- Responsible for Satsuma electronic Management System (which is housed in Qualio).
- Proactively manages controlled document life cycle to ensure state of ongoing compliance.
- Advancing, evolving, and improving all quality systems
- Partners with key stakeholders to develop role-based training curriculums.
- Ensure the proper onboarding and off boarding of all employees or consultants with regard to training.
- Aligns with company-wide departments including Executive level management and Finance to deliver compliance training.
- Communicate with company management on training assignments, curricula review, metrics, and annual training.
- Support regulatory inspections and assisting where needed throughout the company.
- Onboarding and off boarding each Satsuma employee or consultant in the electronic management system
- Revise, review, and approve SOP’s, non-conformances, CAPA, and all other aspects of GxP compliance.
- Assist in the implementation of an electronic quality management system
- Maintains awareness of industry trends and best practices.
- Performs other duties as assigned.
Required Education, Skills, and Experience:
- Education: Bachelor’s degree
- 5+ years of progressive pharmaceutical experience in the biotechnology or pharmaceutical industry.
- Minimum 5-7 years’ experience working in Quality Assurance in a pharmaceutical or biological company, preferred.
- Experience implementing and maintaining pharmaceutical quality systems and electronic management systems.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship or the goals of the organization.
- Ability to lead and to interact and influence as an individual contributor.
For additional information:
Please send your resume or CV to us at careers@satsumarx.com