Boehringer Ingelheim is one of the world's leading research-driven pharmaceutical companies, operating globally in the fields of Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Founded in 1885 and remaining family-owned, the company employs over 53,000 people worldwide and is dedicated to developing innovative therapies that improve the lives of patients and animals. In Spain, the company has a major presence with its headquarters and a significant production site located in Sant Cugat del Vallès, near Barcelona. This location also hosts a Global IT Hub and a Regulatory Affairs center, making it a key destination for international professionals in technology, science, and corporate services. The Spanish division is recognized for its multicultural environment and commitment to professional development.

Founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany, the company started with just 28 employees. Over more than a century, it has evolved into a global pharmaceutical leader while maintaining its status as an independent, family-owned business.

Principal Specialist, QA Auditing

Boehringer Ingelheim

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Description

Leads and conducts external audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures of external suppliers and contractors on behalf of the BIV-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Ensures corrective measures are implemented. Provides transparency of risks from non-compliance. Assesses the implementation and execution of quality / GMP standards at suppliers and contractors to meet FDA/EU and other relevant regulatory requirements, and to prevent and mitigate quality risks. 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Schedule, plan, and prepare for external supplier and contractor audits on behalf of BI pharmaceutical world functions, including Operations, Development, Biopharma and Animal Health, as well as internal audits of BIAH and other BI operating units Operations, Development, Biopharma and Animal Health divisions.
Lead and conduct audits of external suppliers and contractors on behalf of the BIAH-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Prioritize and self manage audit and inspection tasks.
Create and issue the audit report for each audit to submit to BIAH management as a means to ensure SOP(s), facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA, USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external
Perform follow-up actions and oversee investigations of compliance issues noted during audits and inspections or otherwise observed or reported.
Perform follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported. Plan, perform, document, and conduct required post-audit activities for assigned internal and external audits to ensure timely closure of CAPAs. Communicate deviations from the cGMP or other Regulations observed during audits/inspections, recommend appropriate corrective action when necessary, and verify that appropriate corrective actions have been implemented that adequately address any deviations reported during audits to BI Quality Management.
Resolve quality concerns and implement quality improvements by meeting with other department Managers, Staff Managers to assure current methods, procedures or SOP’s meet current standards. Develop, review and/or approve documents associated with Supplier Quality Management (e.g., change controls, specifications, compliance certificates, etc.).
Mentor and train other BI auditors regarding auditing skills, and current and future quality and regulatory trends as part of BI global supplier auditor training. Serve as the subject matter expert to suppliers on compliance topics for BIVI. Acts as a resource for colleagues (especially USA and EU)regarding Good Manufacturing Practice (GMP) for APIs, excipients and Good Distribution Practice, and pharmaceutical products (GDP).
Enable global quality overview of BI suppliers, challenge their status and identify gaps/risks for BI's Supply Chain Integrity.

Requirements

Requires a Bachelor's Degree from an accredited institution in Industrial Engineering, Biology, Chemistry or other related degree.
Requires a Minimum of eight (8) years of progressive experience in comparable quality or auditing function in a GMP regulated environment.
Requires a Quality Engineer / Auditor certification from ASQ or equivalent and qualification as a Lead Auditor.
One to three (1-3) years of experience leading projects.
Advanced/in-depth knowledge of relevant regulations and guidances as well as understanding of scientific methods and processes used to manufacture, test, evaluate and distribute biological and pharmaceutical products.
In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series) and cGMP regulations and related practices required.
Willing and able to travel at least 70% of the time.
Works independently with minimal guidance. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed. Strong independent judgement and decision making abilities required.
Excellent analytical skills.
Excellent conflict resolution and negotiation skills, excellent verbal and written communication skills and the ability to conduct respectful interactions with individuals with diverse views or backgrounds
Ability for work in cross-functional teams and with international alignment.
Knowledge of process improvement concepts and applications in compliance environment.
Required the capability to work with international business partners with intercultural sensitivity.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook).
Ability for work in cross-functional teams and with international alignment.
Physical Demands / Surroundings:
Lifting 25 pounds occasionally
Carrying 25 pounds occasionally
May require extended periods of sitting, walking standing
Climb stairs, bending/stooping, crouching/squatting occasionally
Writing frequently
May have periods of use of Personal Protective Equipment
Visual / Hearing Demands: Contact lenses are allowable. May require extended hours at a computer screen. Must be able to read electronic documents of all types.