What are the responsibilities and job description for the Regulatory Affairs Specialist position at Grifols?
About Grifols
Grifols has been a leader in plasma-derived medicines and transfusion medicine for over a century, working tirelessly to improve the health and well-being of people worldwide.
We develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions, making us a global healthcare company with a family-like culture.
Job Summary
The Plasma Quality Systems Manager will play a critical role in ensuring the effective operation of our plasma donor center by evaluating processes, developing action plans, and implementing quality system processes and corrective actions.
This position involves maintaining oversight of the center's quality management system, ensuring continuous quality improvement by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
The successful candidate will implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance, as well as maintain oversight of the center training program to ensure compliance with program requirements and promote staff competency in their assigned job duties.
This role requires collaboration with the Center Manager to ensure the donor center operates in a manner that maintains product quality, donor suitability, and donor safety.
The Plasma Quality Systems Manager will be responsible for personnel functions, including direction, assignment of work, hiring, development, and training, disciplinary actions, termination, maintenance of personnel records, work schedule, and delegation/follow-up of tasks.
This role also involves overseeing all aspects of internal and external audits, including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
Key Responsibilities
- Develop and implement strategies to improve quality and compliance
- Maintain oversight of the center's quality management system and ensure continuous quality improvement
- Implement SOPs for quality control and regulatory compliance
- Maintain oversight of the center training program and ensure compliance with program requirements
- Collaborate with the Center Manager to ensure the donor center operates safely and effectively
- Oversee all aspects of internal and external audits, including preparation, execution, response, and follow-up
Requirements
- Bachelor of Science degree or equivalent
- Typically requires 2 years of related experience in a medical and/or cGMP regulated environment
- Strong integrity and commitment to quality and compliance
- High level of proficiency with computers
- Proficient in root cause analysis and corrective/preventative actions
- Strong time management abilities
- Proven ability to maintain a high level of quality and compliance and become a valuable member of the center leadership team
- Ability to work with minimal supervision
- Ability to travel when needed for meetings, events, and occasional support of other centers
Working with Us
We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement.
Our company prides itself on its family-like culture, even though we are a global healthcare company with employees in 30 countries.
