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Boehringer Ingelheim · 1 day ago

QA Auditor III

Ridgefield, CT

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $147K/yr

5+ years exp

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 to ensure adherence to regulations and BIPI Standard Operating Procedures, while also conducting audits and addressing compliance issues.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsor Likely

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)

Qualification

Pharmaceutical experienceAuditing experienceRegulationsConflict resolution skillsCommunication skillsLeadership skillsInterpersonal skillsOrganizational skills

Required

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

Benefits

Role specific variable or performance based bonus

Other compensation elements

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees

https://www.boehringer-ingelheim.com/

H1B Sponsorship

Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (13)

2024 (4)

2023 (11)

2022 (7)

2021 (17)

2020 (1)