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.
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:
- Influence policies and procedures for compliance evaluation of regulated activities in area of responsibility within R&D
- Identify areas for and participate in implementation of process improvements and or international harmonization related to compliance across R&D
- Lead and conduct audits; Issue audit reports and perform follow-up actions, as assigned; Conduct 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 as necessary
- 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 straightforward to moderately complex observations noted during audits / inspections; Lead and organize inspection readiness activities
- Maintain acceptable proficiency in technical and non-technical (e.g., interpersonal skills) skills
- 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; Available to act as a resource for colleagues with less experience; Assume the role of manager (when requested)
- Bachelor’s Degree or equivalent with 7 yr pharma experience or equivalent
- Auditing or comparable experience
- Intermediate to advanced knowledge of relevant regulations and guidances; available to act as a resource for colleagues
- Requires moderate to minimal supervision
- Works independently with moderate to minimal guidance
- Independent decision making capability and ability to think conceptually and understand overall impact of decisions
- Independent problem identification and implementation of problem solution
- Very good to excellent conflict resolution and negotiation skills
- Independent representation of department on teams
- Good organization skills resulting in the ability to be self-directed and manage multiple projects
- Very good to Excellent verbal and written communication skills; good interpersonal skills
- Good leadership and mentoring skills
- 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
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.