SR AD, Quality Systems

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is looking for an experienced professional for a key role in Quality Assurance, primarily focused on the design and validation of pharmaceutical facilities. The position entails leading a dedicated team to maintain compliance and quality management across multiple projects.

The ideal candidate will have over ten years of experience in the pharmaceutical industry, an engineering or scientific background, and a strong grasp of qualification management. The role demands excellent communication skills and strategic thinking, with the ability to work effectively in a cross-functional team.

Qualifications

• 10+ years of experience in the pharmaceutical industry.
• Excellent knowledge in qualification and validation management (DQ, IQ, OQ, PQ).
• Fluent in English with excellent communication skills.

Responsibilities

• Lead strategies and ensure oversight regarding the design of facilities.
• Define and align qualification strategies for utilities and facilities.
• Lead a team responsible for quality and compliance.

Skills

Qualification and validation management

Quality Management Systems

Project management

Strategic thinking

Communication skills

Interpersonal relationship skills

Education

Bachelor's Degree in Engineering or scientific degree

Master's Degree preferred

Job description

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

Duties & Responsibilities

• Leads and sets strategies and processes to ensure oversight regarding the design of facilities, utilities and zoning, qualification and validation of facilities and processes, qualification and validation of digital platforms, materials management and production control management between all AH-sites and entities (Operations, Development)
• Define and align qualification, validation strategies for utilities, facilities including zoning concepts for all AH-sites and entities (Operations, Development)
• Leading a team of DMSOs responsible for Quality and Compliance of facilities, utilities and zoning, qualification and validation of facilities and processes, qualification and validation of digital platforms, materials management and production control management
• Develop and lead strategy related to training, support and tools for quality systems
• Deliver and ensure technical and regulatory expertise and guidance to multidisciplinary investment projects
• Ensures direct reports appropriately assess deviations and changes for the relevant Quality Systems
• Interface and influence GMSO network and collaborate with the entire Boehringer Ingelheim network
• Ensures Animal Health standards and specifics are represented and maintained in the Corporate Global Management Quality System

Requirements

• Bachelor's Degree in Engineering or scientific degree required; Masters preferred
• Minimum ten (10) years of relevant experience in pharmaceutical industry
• Excellent knowledge in qualification and validation management (DQ, IQ, OQ, PQ) including sterile and aseptic technologies
• Excellent knowledge of Quality Management Systems
• Decision taking and strategic thinking skills
• Excellent communication skills and fluency in English
• Excellent project management capabilities and experience
• Strong team player in cross‑functional environment, incl. conflict resolution skills
• Strong interpersonal relationship skills
• Good presentation skills
• Compliance & regulatory knowledge
• Financial knowledge (e.g. CCM, COGS/International Costs, NPV, profitability) preferred
• Experience in Boehringer Ingelheim (or other companies) AH or HP Operations network a benefit

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