QA Auditor III

Compensation Data

This position offers a base salary typically between $90,000.00 and $147,000.00 USD.  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.

Description

Boehringer Ingelheim is currently seeking a Quality Assurance Auditor III to support our Quality department at our Ridgefield, CT facility. The QA Auditor III will 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. He / she will 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Participate in establishing 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
• As required, participate in inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility; Investigate and resolve observations noted during audits / inspections; Participate in inspection readiness activities
• Maintain acceptable proficiency in technical and non-technical (e.g., interpersonal skills) skills
• Model 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)

Requirements

• Bachelor´s Degree or equivalent with 5 yr pharma experience or equivalent
• Auditing or comparable experience
• Intermediate knowledge of relevant regulations and guidances; 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
• Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.