(Archived) Good Laboratory Practice Quality Assurance Auditor III/ IV

Description

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 high regard for our employees.

*****Candidate will be hired at level commensurate with experience and education****

Duties & Responsibilities

• Review procedures for compliance to GxP requirements and Company standards
• Update the Master Schedule
• Conduct internal facility audits
• Conduct phase and study audits (e.g. report, data, etc.)
• Issue electronic audit reports and perform follow-up actions
• Provide GLP consultation to Study Directors and across GLP Development areas
• Manage multiple audit assignments and assigned tasks
• Identify areas for and participate in implementation of process improvements and or international harmonization related to compliance across R&D
• As required, participate in inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility; when assigned, investigate and resolve observations noted during audits / inspections; participate in inspection readiness activities
• Obtain acceptable proficiency in technical and non-technical skills (e.g. interpersonal skills)
• 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)

Requirements

Auditor III:
• Bachelor´s Degree or equivalent with 5 yrs. pharma experience or equivalent
• Auditing or comparable experience
• Intermediate knowledge of relevant regulations and guidance’s; available to act as a resource for colleagues
• Requires moderate supervision
• Works independently with moderate guidance
• Independent decision making capability and ability to think conceptually and understand impact of decisions
• Independent problem detection and works with supervisor to devise strategies for solving problems
• Very good conflict resolution and negotiation skills
• Independent representation of department
• 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 skill
• Emerging leadership and mentoring skills
• Respectful interactions with individuals with diverse views or backgrounds

Auditor IV:
• Bachelor´s Degree or equivalent with 7 yrs. 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

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

Compensation Data

This position offers a base salary typically between $102,000 and $175,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.

Desired Skills, Experience and Abilities

• Previous GLP Auditing Experience is highly preferred
• Experience auditing both animal data, and LIMS data (laboratory information management system) preferred
• Experience with maintaining GLP Compliance for a Test Facility desired
• Working knowledge of commercial electronic GxP systems and archival systems desired