Senior Quality Auditor - Remote

Compensation Data

This position offers a base salary typically between $90,000 and $147,000. 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.

Description

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 several 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.

The basic purpose of this role is to effectively provide Quality Oversight via execution of Quality / GMP Audits for Boehringer focusing on the commercial network. The Senior Quality Auditor will continuously improve the supplier / service providers Quality System and effectively communicate audit results throughout the network.

This role will support the North America ACE / Global ACE organization when improvement opportunities are identified or training / mentoring is needed.

Duties & Responsibilities

• Leads and conducts audits for all Boehringer OPUs, including Human Pharma, Biopharma, Animal Health, and Development.
• Performs audits for API, excipients, packaging material, intermediates, starting materials, and service suppliers according to a predefined plan to assess the quality systems and the GMP (or other standard / regulations) compliance level of suppliers.
• Actively prepares and performs the audits, including the issuance of audit agendas, reports, and performance of follow-up actions as assigned.
• Oversees investigations of compliance issues observed / noted during audits.
• Works with suppliers to drive quality and compliance improvements stemming from audit outcomes.
• Leads a centralized process for negotiation of confidentiality agreements when required by suppliers within the U.S. to conduct a Quality Audit.
• Support the qualification of new ACE Auditors through mentoring, training, knowledge sharing and continuous learning.

Requirements

Required skills :

Critical soft-skill competencies :

Desired Skills, Experience and Abilities

Eligibility Requirements :

Salary : $90,000 - $147,000