Manager, Validation - CSVC

Description:

Description\:

This position is responsible for directing implementation and administration of the GXP Computer System Validation & Compliance (CSVC) Quality System for both Pharmaceuticals and Vaccines at the facility. The position is critical to the compliance effort and is responsible for assuring compliance of CSVC systems to current cGMP, FDA, EU, USDA and BI corporate requirements.

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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities\:

• Provides leadership and strategic direction to the CSVC team; manage and retain talent in the CSVC group. Responsible for management of expenses, budget and personnel performance. Provide feedback, coaching as needed.
• Approves, reviews, authors and executes programs, protocols, procedures and policies. Provides technical guidance, training and oversight for the implementation of computerized systems assuring GXP compliance.
• Leads and/or participates in special projects or duties as assigned and ensure department and individual priorities are aligned with corporate, operational and functional priorities.
• Development and maintenance of KPIs, metrics and applicable monthly reports; identification and implementation of continuous process improvement initiatives.
• Maintains comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant computerized systems and processes.
• Identifies current trends in regulatory compliance for all validation procedures for equipment, systems and processes. Implements and updates the validation master plan (VMP) to assure compliance with regulatory and corporate requirements.

Requirements\:

• Minimum of Bachelor’s degree from an accredited institution in relevant field with a focus in Computer Systems, Information Technology, Engineering or relevant discipline and a minimum of seven (7) years GMP validation experience in a GMP or regulated manufacturing or similar environment.
• In lieu of a degree, a minimum of twelve (12) years GMP validation experience in a GMP or regulated manufacturing or similar environment
• Experience must be inclusive of at least three (3) years in a leadership role leading people and/or projects.
• A minimum of five (5) years experience supporting Quality/QA or relevant CSVC computer systems and end-user applications in GMP manufacturing site or similar environment. Experience must be inclusive of evaluating and testing quality/QA or relevant computer systems and end-user applications. Strong theoretical and practical knowledge of information systems and one technical discipline; programming experience preferred; this requirement is essential for effective compliance assessments of the equipment, computerized system applications and infrastructure
• Thorough understanding of FDA, EU and other regulatory requirements and applicability.
• Must possess an understanding of other business disciplines to ensure the ability to assess compliance needs of all functional areas of the organization, with special emphasis on business systems, manufacturing, and laboratory functions.
• Exceptional written and verbal communication skills to transmit difficult technical information in meaningful ways to the supported business processes.

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

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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