To implement the BIAH Global Quality Program designed to assure the adherence of facilities, operations, studies, reports and practices to regulations (e.g. FDA, EMEA, NRC, DEA USDA) as well as to BIAH Standard Operating Procedures (SOPs), BIAH policies, regulatory guidelines and good scientific and documentation practices. To inform BIAH Management of deviations from the GCP, GLP, other Regulations observed during audits/inspections, to recommend appropriate corrective action when necessary and to verify that appropriate corrective actions have been implemented that adequately address any deviations reported during inspection. Ensure that all procedures and processes, in preparation for regulatory inspections are well documented and supported by ongoing training and monitoring.
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:
- Review protocols, reports, and data both on paper and electronically generated.
- Organize and lead Global Innovation QA associated projects locally and/or internationally (as required)
- Foster a work environment that supports quality, productivity and compliance.
- Lead and conduct audits, issue audit reports, and perform follow-up actions as assigned
- Oversee investigations of compliance issues noted during audits and inspections or otherwise observed or reported.
- Review/audit compliance documents, SOPs and validation protocols as assigned
- Report findings to Global Innovation management.
- In the absence of the manager or when assigned
- Organize and host inspections and audits by regulatory agencies, BIAH compliance groups, and consultants in area of responsibility
- Investigate and resolve moderately complex observations noted during audits / inspections
- Lead and organize inspection readiness activities.
- Maintain expert proficiency in technical and non-technical (e.g., interpersonal skills) skills
- Maintain proficiency on regulatory compliance issues through industry contacts, journal articles, professional meetings and seminars.
- Train new personnel as required and develop and implement training programs in the regulatory requirements as requested.
- Lead programs designed to ensure regulatory compliance of Quality Systems and foster an environment for Global Innovation QA personnel to initiate improvements
- Perform all company business in accordance with all regulations (e.g. FDA, EMEA, USDA, NRC, DEA) and company policies and procedures.
- Knowledge and competency pertaining to DA, EMEA, NRC, DEA USDA as well as to BIAH Standard Operating Procedures (SOPs), BIAH policies, regulatory guidelines and policies, regulatory guidelines and good scientific and documentation practices.
- Bachelor’s degree from an accredited institution or equivalent with eight (8) years biological or pharmaceutical experience or equivalent.
- Auditing or comparable experience
- Advanced/In-depth knowledge of relevant regulations and guidance
- Acts as a resource for colleagues.
- Recognized as expert by clients and colleagues
- Requires minimal supervision
- Works independently with minimal guidance
- Ability to make decisions for department in manager’s absence
- Independent problem detection and implementation of problem solution
- Ability to formulate strategies for performing regulated activities based on knowledge of regulations and guidance
- Excellent conflict resolution and negotiation skills
- Independent representation of department
- Excellent organization skills resulting in the ability to be self-directed and manage multiple cross-functional programs and projects
- Excellent verbal and written communication skills
- Good interpersonal skills
- Excellent leadership and mentoring skills
- Knowledge of process improvement concepts and applications in R&D environment
- Respectful interactions with individuals with diverse views or backgrounds
- 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