Manager, Quality & Compliance

Boehringer Ingelheim GmbH; Northern (KY); Hybrid; 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

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