The individual will provide oversight for Steriles Manufacturing Quality Assurance as well as clients. Strong decision making skills are required for this role. Previous Sterile environment experience is recommended.
The individual will interact with varying levels of staff within the organization as well as with customers and regulatory agencies. The individual will be accountable for interactions that enhance the QA reputation oand that set the example for others to follow. The person in this role will act as a working supervisor in specfic areas of responsibility within QA and will be responsible for making decisions regarding compliance of processes used to make product and to maintain the controlled environment.
Coordinates Quality Assurance (QA) activities and programs such as auditing, record review, final product functions, complaints, document management, APR, oversight of quality systems and/or investigations within QA.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Complies with all job-related safety and other training requirements. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Supervises staff who perform quality and manufacturing audits, record review, final product release functions, complaints, APR, validation and/or investigations at the Site, and quality oversight of facilities, equipment, systems, manufacturing and laboratories at the Site.
Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
Supports systems and new product introduction as a technical resource by providing assessment technical expertise, problem solving, and strategies for problem prevention.
Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
Manages resources by budgeting for and assuring availability of staff to meet business needs.
Maintains current knowledge of emerging trends and technologies. Serves as a technical resource.
Ensures staff has performance plans with metrics in place. Reviews are conducted twice a year (mid-year and annually).
Identifies and manages performance/discipline issues.
Provides training and/or opportunities for career development of staff.
Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
Performs other duties as assigned.
Bachelor's Degree in Science
Background in Steriles
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.