To implement the BIPI Regulatory Compliance 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 BIPI Standard Operating Procedures (SOPs), BIPI policies, regulatory guidelines and good scientific and documentation practices.
To inform BIPI Management of deviations from the cGMP, 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 inspections.
Ensure that all procedures and processes, in preparation for regulatory inspections are well documented and supported by ongoing training and monitoring.
Build culture of compliance and quality by implementing operational excellence and quality management programs.
Develop and manage business processes that optimize productivity, quality, compliance, and resource utilization across the development functions.
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:
- Lead teams to develop policies and procedures for compliance evaluation of regulated activities in area of responsibility within R&D
- Organize and lead process improvement projects locally and/or internationally (as required); Foster a work environment that supports quality, productivity and compliance; Partner with Research, Development and other business partners to prioritize and manage process improvement projects
- 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 Research or Development management
- In the absence of the manager or when assigned; organize and host inspections and audits by regulatory agencies, BI 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
- Model and coach colleagues in effective and constructive communication behaviors and interactions with technical departments both orally and in writing
- Train new personnel as required and develop and implement training programs in the regulatory requirements as requested; Acts as a resource for colleagues with less experience. Assume the role of manager when requested)
- Manage programs designed to ensure regulatory compliance of Quality Systems and foster an environment for R&D 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
- Bachelor’s degree or equivalent with 8 years pharma experience or equivalent
- Extensive knowledge of GMP regulations (e.g., FDA, EMEA) and GDP, GLP, and GCP understanding; acts as a resource for colleagues.
- Demonstrated skill with quality audits/inspections and supplier qualification
- Quality oversight of vendors and suppliers to ensure GMP compliance
- Experience in preparing and negotiating Quality Assurance Agreements (QAAs)
- 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 guidances
- 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