Responsible for leading the day to day operations of the group pertaining to investigation of deviations, and the subsequent documentation of the deviation, root cause analysis, CAPA, and impact assessment of the event. Responsible for implementing procedures to assure compliance with EU, USDA, and corporate requirements; and ensuring final investigation reports meet regulatory and BIAH requirements.
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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Coordinates the overall operation of the group. Prioritizes work, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews. Maintains key performance indicators for operational investigations.
- Maintains personal knowledge skills in the awareness of current regulatory and corporate practices.
- Review and approve laboratory and manufacturing investigations to ensure compliance with BIAH policies and applicable regulatory guidance. Coordinate investigations across all functions within operations,ensure effective root cause analysis, and develop corrective and preventive actions for associated events relating to biological production operations and associated quality systems. Ensure timely completion of investigations per procedures, and the implementation and completion of corrective and preventive actions.
- Completes all assigned training by target due dates as assigned by BIAH.
- Assists in development of training plans and trains others, including training outside of area of responsibility.
- Assists as needed in development and maintenance of training curricula and qualifications.
- Demonstrate high ethical and professional standards with all business contacts in order to maintain BIAH’s excellent reputation in the community.
- Four (4) year degree from an accredited institution in a scientific discipline
- Minimum eight (8) years of experience in regulated industry
- Well versed in regulatory requirements
- Ability to effectively manage people.
- Effective interpersonal skills with a diverse group of individuals at all organizational levels
- Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations
- Ability to use technical knowledge to solve problems
- Proficiency in relevant computer software and programs associated with area.
- Excellent written and verbal communication skills
- Attention to detail and commitment to customer service
- An understanding of biological manufacturing, regulatory requirements, as well as good communication and strong writing skills are required to perform and document the investigations. Well versed in regulatory requirements
- Requires the ability to utilize computer programs such as Microsoft suite, GoTrack, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.
- A basic understanding of EU GMPs, Outlines of Production, 9 CFR and compliance requirements is required for this position in order to properly assess product, procedures, recommend/drive improvements and make correct decisions.
- 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