Manager, Quality & Compliance

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is seeking an experienced QA leader to oversee release quality for components, materials, and products, ensuring adherence to FDA/GLP/good practice standards. The role manages CAPA, deviations, audits, and proper documentation, while guiding trend analysis and continuous improvement.

The candidate will lead a team, drive QA systems, and collaborate across functions to uphold BI's quality commitments and regulatory compliance in a global biopharmaceutical environment.

Qualifications

• Bachelor's degree or advanced degree in a scientific discipline.
• 8+ years in regulated industry and QA, including 3+ years leadership.
• Well versed in cGMP/GLP and BI requirements.
• Ability to manage a substantial team and diverse stakeholders.
• Strong data evaluation, interpretation, and sound recommendations.
• Excellent written and verbal communication.

Responsibilities

• Manage department operations and budget within defined constraints.
• Set priorities, drive QA improvements, and conduct performance reviews.
• Develop and implement procedures and policies for compliance.
• Review and revise testing procedures and specifications.
• Ensure SOPs, safety procedures, and controlled documents are followed.
• Oversee deviations, product complaints, validation docs, and approval processes.

Skills

Leadership

People management

Regulatory knowledge

Quality Assurance

Analytical thinking

Communication skills

Problem solving

Attention to detail

Education

Bachelor's degree

Job description

Description

Responsible for management, budgeting and day to day operations of Quality Assurance pertaining to release of components, raw materials, products, internal and external vendor audits, GXP training, and administration of key QA systems such as CAPA, deviations, complaint management, validation reviews, change control, controlled documents such as SOPs, Batch records etc . Responsible for implementing procedures to assure compliance with FDA, EU, USDA, and corporate requirements. Responsible for all quality improvement initiatives arising out of audit and inspectional findings.

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

• Manages the overall operation of the department.
• Prioritizes work, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews.
• Interprets requirements for compliance and creates, develops, and implements Departmental procedures and policies.
• Initiates review and revision of testing procedures and specifications.
• Ensures that policies, SOPs, and safety procedures are instituted and followed.
• Perform final QA review and approval on deviation, product complaints, validation documentation, and and other appropriate documents.
• Manages department expenditures and maintains within defined budget.
• Maintains personal knowledge skills in the awareness of current regulatory and corporate practices.
• Responsible for sourcing, introducing, and bringing new instrumentation/technology into the department.
• Responsible for providing technical guidance, training and oversight for the department and its members.
• Assists in development and oversight of Quality Systems.
• Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.
• When violations are noted/observed they are to be immediately reported to management.
• Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH´s excellent reputation in the community.
• The position is responsible for the management and production oversight of intermediates and finished products, along with method development.

Requirements

• Bachelor´s Degree from an accredited institution or advanced degree in scientific discipline
• Minimum eight (8) years of experience in regulated industry and QA, inclusive of three (3) years previous leadership experience
• Well versed in all regulatory requirements, inclusive of cGMP/GLP and BI requirements
• Ability to effectively manage a substantial number of people.
• Effective interpersonal skills with a diverse group of individuals at all organizational levels
• Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations
• Ability to use technical knowledge to solve problems
• Proficiency in relevant computer software and programs associated with area.
• Excellent written and verbal communication skills
• Attention to detail and commitment to customer service

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com