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AD, HPS Strategic Network Quality & Compliance (Remote)

Boehringer Ingelheim

Last Updated: 6/12/24

Job Description

Compensation Data

This position offers a base salary typically between $120,000.00 and $205,000.00.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.

Description

The AD, One HP Strategic Network Quality & Compliance is responsible for US and Global compliance intelligence and interpretation of applicable laws, regulations, and guidance as they pertain to the One HP (HP & BIO) Network sites to facilitate maintaining and sustaining Inspection readiness across the One HP Network. This role is responsible for identifying the risks associated with the regulatory requirements, providing direction to the organization in effectively interpreting, identification of gaps and development of Network wide implementation strategy(s) for implementation. The incumbent will enhance authority inspection knowledge through site specific consultation, project management, baseline assessment and training. This role develops and maintains virtual knowledge management platform to support global regulatory inspection lifecycle (Preparation logistics, Readiness management, Preparation/logistics, Resources (Internal/external), Post inspection response approaches/strategies)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 several 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

  • Maintains up to date, current understanding of requirements for compliance with US and other key International regulatory authorities (EMA, China, Russia, TGA etc.) applicable to cGMP, Quality systems, Product safety and security etc.
  • Develops, maintains, and sustains a Virtual Knowledge management platform as an on-going resource to all One HP Network sites to support regulatory audit preparation and logistics both pre and post inspection.
  • Implements processes to share industry trends, key learnings, and best practices regarding regulatory authorities.
  • Identifies necessary process improvements for the Network and initiates inter-company CAPAs as applicable.
  • Composes and disseminates standardized internal communications on important compliance developments, company policies and procedures.
  • Develops, initiates and coordinates baseline assessments (as needed) and training on inspection preparation, gap assessment and risk management, authority interactions, and other related topics critical to maintaining and sustaining site inspection readiness.
  • Project management: supports sites as assigned on key projects that enable and sustain inspection readiness.

Requirements

  • Bachelor’s Degree with focus in Chemistry, Biology, Pharmaceutical Science, or related field preferred.
  • A minimum ten (10) years’ relevant work experience in a regulated pharmaceutical environment. Experience can be a combination of Quality Assurance, Regulatory Compliance, Quality Control and Project Management.
  • Preferred experience with Biopharma and regulators overseeing Biologics compliance (i.e., CBER).
  • Strong communication skills (Verbal and Written) in English with Spanish(preferred).
  • Demonstrated negotiation and influencing skills; risk and scientific decision making.
  • Demonstrated project management capabilities. Establish project teams and effectively execute the DMAIC process to improve processes and procedures.
  • Demonstrated proficiency with electronic media, leverages technology to strengthen connectivity and access to information. Ability to develop and effectively execute electronic solutions to enhance training and knowledge management.
  • Strong inter-cultural skills.
  • Ability to establish and execute effective training.
  • Ability to travel domestically and internationally (approximately 30%).



Company Details

Binger Strasse, Germany