AD, Quality Systems

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.

Oversee the management of change control, document control, document archival, complaints, annual product reviews, translation of corporate policies into site level procedures, and CAPA/TrackWise to ensure compliance of the programs to applicable current domestic and international regulations, guidelines, industry practice and internal policies/procedures.  Responsible for assisting with inspection readiness activities, leading the inspection preparation team that supports the inspection team during regulatory agency inspections, and interacting with inspectors. 

Will have responsibility for overseeing the management of the internal audit program and supplier qualification program. Responsible for ensuring compliance to local site procedures, corporate procedures and regulatory requirements. This position may serve as deputy for Director, Quality and Compliance position in their absence.

Light Work (Level 2) – Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently.

Duties & Responsibilities

• Oversee management of Internal Audit, Supplier Quality Management, Change Control, Document Control, complaints, CAPA, and Site Implementation of Corporate Procedures to ensure compliance of the programs to applicable current domestic and international regulations, guidelines, industry practice and internal policies/procedures.
• Identify and resolve real or potential quality issues; develop and maintain KPIs, metrics and monthly report for Quality; identify and implement continuous process improvement initiatives.
• Ensure all department employees are trained in applicable regulatory requirements, company procedures, and relevant systems. 
• Manage and retain talent in the Quality Systems group.  Develop MAG Plans for self and staff to align with corporate, operational and functional goals and objectives and establish development plan.  Conduct employee performance evaluations in accordance with HR policies and procedures. Provide feedback, coaching and disciplinary action (when warranted) in a timely manner and in accordance with current HR policies and procedures.
• Assist with inspection readiness activities, lead the inspection preparation team that supports the inspection team during regulatory agency inspections, and interact with inspectors/auditors as required.
• Develop assigned documents, to include but not limited annual product reviews, standard operating procedures, work instructions, policies, CAPA. Perform QA review and approval of assigned documents, and perform assigned internal audits.
• Lead and/or participate in special projects or duties as assigned and ensure department and individual priorities are aligned with corporate, operational and functional priorities.
• Manage expense and capital department budget within established parameters.

Requirements

• Bachelor's Degree in relevant scientific discipline or business related field.
• In addition to bachelor's degree, a minimum of 10 years relevant experience inclusive of management of change control, document control, document archival, complaints, annual product reviews, and translation of corporate policies.  
• With Master's degree, a minimum of 8 years relevant experience inclusive of management of change control, document control, document archival, complaints, annual product reviews, and translation of corporate policies.

Experience must be inclusive of:

• Minimum 5 years of experience in Quality Assurance in a regulated industry.
• Minimum 5 years previous leadership experience.

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