Leading and representation site audits where needed.
Independently determine approach to managing daily operations; guided by general policies and management guidance
Develop or contribute to the development of procedures and standards by which others will operate.
Interpret and execute standards and procedures directly affecting work activities
Develops and communicates goals and objectives to staff and key partners
Monitor goal performance and coordinate action for improvement of QI performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources.
Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership
Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change
Reviewing and approving relevant documents, procedures, records.
Approving deviations, representing QI on project teams
Communication of Quality System status to Sr. Leadership in multiple forums; maintaining the metric reporting for site performance.
Note: Other responsibilities, accountabilities or decision authorities may be assigned Basic Qualifications
Doctorate degree and 2 years Quality experience
Master s degree and 6 years of Quality experience
Bachelor s degree or and 8 years of Quality experience
Associate s degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
At least 2 years of leadership experience leading teams, projects, programs
Bachelor s Degree in Life Sciences, Engineering or related field
8 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
5 + years of project management experience
Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control
Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment
Ability to manage to establish timelines and deliver results to meet or exceed department and company goals and objectives.
Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations
Ability to communicate clearly, both written and oral, facilitate discussions and present to audiences at all levels of a site organization
Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs
Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing