Quality Assurance & Compliance Lead

Boehringer Ingelheim GmbH; Northern (KY); On-site; USD 100,000 - 140,000; Full time

Job summary

Boehringer Ingelheim is seeking a Quality Assurance leader to manage the QA department, oversee release of components, raw materials, and finished products, and ensure compliance with cGMP/GLP and FDA/EU/USDA requirements.

The role includes budgeting, audits, CAPA, deviations, training, change control, and the development of quality systems, with responsibility for supplier and internal audits and cross-functional collaboration.

Qualifications

• 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

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.

Skills

Leadership

Interpersonal skills

Data interpretation

Problem solving

Communication (written & verbal)

Attention to detail

Customer service mindset

Education

Bachelor's Degree in scientific discipline

Advanced degree (preferred)

Job description

Boehringer Ingelheim is seeking a Quality Assurance leader to manage the QA department, oversee release of components, raw materials, and finished products, and ensure compliance with cGMP/GLP and FDA/EU/USDA requirements.

The role includes budgeting, audits, CAPA, deviations, training, change control, and the development of quality systems, with responsibility for supplier and internal audits and cross-functional collaboration.