Senior Specialist, Quality Systems
We are seeking a highly skilled Senior Quality Systems Specialist to join a growing Contract Development and Manufacturing Organization (CDMO). In this role, you will be responsible for managing and enhancing quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. You will lead efforts to develop, implement, and maintain quality systems, including document control, CAPA, change control, and risk management processes. As a senior team member, you will collaborate with cross-functional teams to ensure the effective delivery of quality solutions while supporting continuous improvement initiatives.
Key Responsibilities:
- Oversee the development, implementation, and maintenance of quality systems to ensure compliance with GMP and other regulatory guidelines.
- Lead the management of CAPA, deviations, and change controls.
- Provide expertise in quality system processes and procedures, ensuring consistency and compliance across all operations.
- Support internal and external audits and inspections.
- Collaborate with manufacturing, regulatory, and other departments to drive quality initiatives and resolve quality-related issues.
- Analyze data to identify trends, initiate corrective actions, and drive continuous improvement efforts.
Qualifications:
- Bachelor's degree in Life Sciences, Engineering, or related field.
- 5+ years of experience in a Quality Systems role within the pharmaceutical, biotechnology, or CDMO industries.
- Strong understanding of FDA regulations, GMP, and industry standards (ISO, ICH).
- Proven ability to lead quality projects and work cross-functionally in a fast-paced environment.
