SR AD, Quality Systems

BoehringerPRD • Saint Joseph, MI

1d

About The Position

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, Quality Systems leads functions and sets strategy to ensure all Quality and Compliance systems/procedures for 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. The function leads the DMSO roles for the aforementioned systems and processes for all sites within the AH division.

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.
• 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.

Nice To Haves

• 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.

Responsibilities

• Leads and set 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior