Boehringer Ingelheim Pharmaceuticals, Inc

SR AD, Quality Systems

Boehringer Ingelheim Pharmaceuticals, Inc • $100K — $130K *
Saint Joseph, MI 49085In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering or scientific field required; Master's preferred.
  • Minimum of 10 years' experience in the pharmaceutical industry.
  • Expertise in qualification and validation management (DQ, IQ, OQ, PQ), particularly in sterile and aseptic technologies.
  • Strong knowledge of Quality Management Systems.
  • Excellent project management skills with a focus on decision-making and strategic thinking.

Responsibilities

  • Lead and implement strategies for oversight of facility design, qualification, and validation across multiple sites.
  • Define qualification and validation strategies for utilities and facilities within the AH division.
  • Manage a team of DMSOs to ensure compliance and quality of facilities and processes.
  • Develop training strategies and support tools for quality systems implementation.
  • Provide technical and regulatory guidance for multidisciplinary projects.
  • Assess deviations and changes in relevant Quality Systems with direct reports.
  • Collaborate with the GMSO network and align with the broader Boehringer Ingelheim system.
  • Maintain Animal Health standards in the Corporate Global Management Quality System.

Benefits

  • Comprehensive training programs and resources for professional development.
  • Opportunity to work with a multidisciplinary team in a global company.
  • Exposure to diverse project management responsibilities in quality systems.
  • Collaboration with a wide network of professionals across the organization.
Full Job Description
Description

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

Duties & 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.


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.


Desired Skills, Experience and Abilities

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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