Together with the Head of North America (NA) Audit Center of Excellence (ACE) and the local Supplier Qualification Management System Owners (SQ-MSO) creates and maintains the annual audit schedule. Responsible for follow up regarding audit schedule adherence and coordination and monitoring of Corrective Actions and Preventative Actions (CAPA) with the Suppliers.

Ensures process compliance for supplier quality audits. Manages the archival of documents and interfaces to global data bases.

Maintains interface to business partners (Sourcing, Quality Units, Matrix Teams) both locally (i.e. North America) and globally.

Leads and conducts audits and assesses the quality / current Good Manufacturing Practice (cGMP)compliance status of external suppliers and contractors on behalf of the BI manufacturing world, including Human Pharma, Biopharma, Animal Health and R&D Development. Ensures corrective measures are implemented with suppliers. Provides transparency of risks from non-compliance.

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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

Duties & Responsibilities:

Has oversight and monitors of supplier’s CAPAs to ensure timely closure of CAPAs is achieved. Is responsible for ensuring timely closure of supplier CAPA's is achieved. Will be the primary interface with global suppliers to achieve agreement on CAPA plans stemming from audit observations. Work with the suppliers on implementation of corrective actions per established commitment dates. Collect objective evidence and close-out CAPA's. Monitor CAPA data and perform data analysis to identify areas for improvement. Utilizes global metrics to track CAPA performance. Ensure processes are in compliance with regulations and corporate procedures.
Escalates issues resulting from CAPAs to provide transparency to management.
Leads and conducts audits for all BI OPUs, including Human Pharma, Biopharma, Animal Health, and R&D Development. Performs audits for APIs, excipients, packaging material, intermediates, starting materials, and service suppliers according to a pre-defined 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 noted during audits and inspections or otherwise observed or reported.
Checks audit documentation created by auditors prior to archival. Reviews to ensure correctness and adherence to quality requirements.
Archives all audit documents in IDEA for Gen. Manages and updates information in the global supplier management audit database.
Together with other global functions, maintains the global supplier lists based on feedback from SQ-MSOs within the NA ACE.
Prepares documentation and coordinates audit schedules with corresponding Auditors, SQ-MSOs, BI Business Units, and Sourcing Department. Creates and maintains the Audit Schedule for the NA ACE. Utilizes global metrics to track regional performance of the ACE.
Identifies and escalates risks for BI in case of delays in order to address them properly.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.

In order to apply for this position, you should register online.

Bachelor’s degree from an accredited institution in Pharmaceutics, Biopharmaceuticals or Veterinary discipline is required.
Other degree focus acceptable with appropriate experience.
Minimum of five (5) years of experience within a GMP regulated environment, preferably pharmaceuticals, medical devices, biopharma, veterinary, or other life science industries.
Knowledge of FDA, cGMP, EU regulations and ISO standards.
Expert working with IT systems and data bases
Fluent with excel spreadsheets and generating data analysis graphs and presentations.
Possesses excellent communication skills with the ability to influence
Ability to manage multiple priorities
Drive for Results
Accountability
Agility
Sense of Urgency
Communication
Teamwork and Collaboration
Project and Program Management
Leading Employees & Projects
Broad knowledge of international GMP regulations and other standards such as ISO and ICH is required.
Must have previous experience with Corrective and Preventive Actions (CAPA) including conducting investigations, developing CAPA plans, implementing CAPA's, and compiling objective evidence.
Acts as a GMP auditor for Suppliers
Must have knowledge and experience with cGMPs and global regulatory requirements and standards.
Must be able to assess compliance and appropriateness of follow up activities.

Desired Skills, Experience and Abilities:

Experience as a Project Manager
Experience as a GMP auditor
Fluent in Spanish reading and writing
Experience with electronic CAPA systems such as Go-Track

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