[Remote] QA Auditor III

Note: The job is a remote job and is open to candidates in USA. 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 adherence to regulations and BIPI Standard Operating Procedures, while also informing management of deviations and recommending corrective actions.

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) Skills
• 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 Company Overview
• Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship
• Boehringer Ingelheim has a track record of offering H1B sponsorships, with 13 in 2025, 4 in 2024, 11 in 2023, 7 in 2022, 17 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job

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