AD, Quality and Compliance

Boehringer Ingelheim; Gainesville (GA); On-site; USD 110,000 - 140,000; Full time

Job summary

Boehringer Ingelheim is seeking a senior QA Release SME who will provide technical direction for product disposition and ensure compliance with EU, USDA and corporate requirements.

This role supports the Quality & Compliance department, leads investigations, CAPA and regulatory inspections, and mentors QA staff across sites during acquisitions and divestitures.

Qualifications

• Bachelor's degree in a scientific discipline or relevant field.
• A minimum of 10 years of strategic experience in QA systems and processes including deviation management within a GMP regulated manufacturing facility or similar environment.
• Experience must include 6 years leading people, projects and leaders.
• Preferred regulatory experience in FDA and/or EU regulated environment.
• Sterile product manufacturing experience preferred.

Responsibilities

• Track and report status of action items to assure Quality systems are in place across sites.
• Review and approve investigations to ensure compliance with BIVI policies and regulatory guidance.
• Coordinate investigations, ensure root cause analysis and CAPA development.
• Assist in policy to ensure compliance with EU, FDA and corporate requirements.
• Support QA Release functions and regulatory inspections; assist training as needed.

Skills

QA systems

Regulatory compliance

Leadership

Education

Bachelor's degree in a scientific discipline

Job description

Description 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.

Description 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. The basic purpose of this position is to provide technical direction and serve as a subject matter expert (SME) for product disposition activities to assure that Quality systems and processes are in place. Also, be an SME for the documentation of the deviation, root cause analysis, CAPA, and impact assessment of the event. Responsible for implementing procedures to assure compliance with EU, USDA, and corporate requirements; and ensuring final investigation reports meet regulatory and BIAH requirements. This position will indirectly support the Quality and Compliance department according to company policies and corporate business plans and to provide technical support to QA Release functions. Participate and helps lead regulatory inspection. This position also serves as a deputy (backup) to the Sr. Associate Director in the event of their absence.

Duties & Responsibilities

• Responsible for tracking and reporting status of all action items on a routine basis to assure Quality systems are in place to support the business across sites during company acquisitions and divestures
• Assures all site processes are in place to support the business. Review and approve laboratory and manufacturing investigations to ensure compliance with BIVI policies and applicable regulatory guidance. Coordinate investigations across all functions within operations, ensure effective root cause analysis, and develop corrective and preventive actions for associated events relating to biological production operations and associated quality systems. Ensure timely completion of investigations per procedures and the implementation and completion of corrective and preventive actions.

Training

• Completes all assigned training by target due dates as assigned by BIVI.
• Assists in development of training plans and trains others, including training outside of area of responsibility.
• Assists as needed in development and maintenance of training curricula.

Indirectly supports the following Quality & Compliance activities as needed

• Deviations/CAPA
• Change Control
• Regulatory Activities
• QA management activities, including staffing, budget, compensation, KPIs, strategic planning.
• Audits/Inspections

May have Management Responsibilities to include

• Manages department expenses.
• Communicates staffing expectations to applicable QA staff.
• Develops assigned direct reports. t
• Identifies equipment/tools needed for QA Release.
• Provides input for performance reviews and compensation approvals.
• Performs data generation & provides reports/updates for Quality Management reviews
• Performs business and strategic planning for area of responsibility in alignment with Company objectives

Requirements

• Bachelor's degree in a scientific discipline or relevant field.
• A minimum of 10 years of strategic experience in QA systems and processes including deviation management within in a GMP regulated manufacturing facility or similar environment.
• Experience must be inclusive of 6 years leading people, projects and leaders.
• Preferred regulatory experience in FDA and/or EU regulated environment.
• Sterile product manufacturing experience preferred.

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

Our Company

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.

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.

Visit https://www.boehringer-ingelheim.com