Description
Leads and delivers AAI through managing assigned department and modeling company best practices and expectations. Responsible for management and compliance of personnel, equipment and laboratories. Responsible for budgeting and day to day operations of Bio QC pertaining to sectional requirements and testing to support the release or rejection of components, raw materials, products of assigned department(s). Manage and drive GXP training, and administration of key QA systems such as CAPA, deviations, complaint management, validation reviews, change control, controlled documents such as SOPs, Bench Records, etc. Responsible for implementing procedures to assure global compliance with EU, USDA, and corporate requirements. Responsible for quality improvement initiatives arising out of audit and inspection findings. Responsible for compliance, collaboration and communication of any data used to provide the release of product and expediting through put for investigation of product to the customer Departments and Quality Assurance. This position may serve as a backup to the Director, Quality Control or direct supervisor in the event of their absence. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
- Manages the overall operation of the department. Prioritizes work, provide training, leads investigations, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews.
- Interprets requirements for compliance and creates, develops, and implements Departmental procedures and GXP's. Initiates review and revision of testing procedures and specifications. Ensures that policies, SOPs, and safety procedures are instituted and followed.
- Manages expenditures relating to laboratory operations and instrumentation. Budget, expense and CAPEX oversight of assigned area(s).
- Maintains personal knowledge skills in the awareness of current regulatory and corporate practices. Ensures personnel have regulatory and compliance training and skills to perform assigned work.
- Responsible for sourcing, introducing, and bringing new instrumentation/technology into the department.
Requirements
- Must have bachelor's degree in a relevant scientific discipline and a minimum of 6 years of related quality control and/or quality assurance experience in a GMP regulated manufacturing or similar environment. Alternatively, incumbent may have a master's degree in a relevant scientific discipline and a minimum of 4 years of related quality control and/or quality assurance experience in a GMP regulated manufacturing or similar environment OR a PHD in a relevant scientific discipline and a minimum of 2 years of related quality control and/or quality assurance experience in a GMP regulated manufacturing or similar environment. Experience must inclusive of at least 2 years leading people, complex projects and/or leaders.
- Business & Technical Knowledge - Demonstrating, Accountability
- Customer Orientation - Influencing, Entrepreneurship
- Delivering Results - Influencing, Agility, Accountability
- External Customer/Stakeholder Focus - Demonstrating, Agility
- Fast and Focused Execution - Influencing, Agility
- Innovation and Change - Influencing, Entrepreneurship
- Teamwork and Collaboration - Influencing, Accountability, Agility
- Winning Vision - Demonstrating, Accountability, Agility, Entrepreneurship
- Analytical Thinking - Level 3, Demonstrating,
- Business Acumen - Demonstrating, Entrepreneurship
- Communicates Effectively - Demonstrating, Influencing, Accountability
- Planning and Organization - Demonstrating, Influencing
- Quality Orientation - Demonstrating, Influencing & Agility
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
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