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

• Bachelor's Degree in Pharmaceuticals, Chemistry, Biology, or other related life science required.

Required skills:

• Expert knowledge of current Quality/GMP/GDP/ISO relevant regulations.
• Minimum of five (5) years' experience in a GMP/GDP regulated environment.
• Extensive experience auditing externals (e.g. - CMOs, Suppliers, Service Providers).
• Experience in BioPharma processing activities preferred.
• Experience in Computer System Validation preferred.
• Experience in API manufacturing preferred.
• Language skills: English (mandatory), Spanish (preferred).

Critical soft-skill competencies:

• Conflict management skills.
• Strong communication and networking skills.
• Strong judgment and decision-making skills.
• Capabilities to work with international business partners with inter-cultural sensitivity.
• Experience with executing audits and collaborating with external facing contacts to achieve benefit for the company.

Desired Skills, Experience and Abilities

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.