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Astrix Technology Business Development Project Manager in Ridgefield, Connecticut

Business Development Project Manager

Regulatory Affairs

Ridgefield, CT, US

Pay Rate Low: 60.00 | Pay Rate High: 64.00

  • Added - 02/12/2024

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The Business Development & Continuity Expert represents the Pharmaceutical Development department during global regulatory audits and inspections.

Pay: Up to $60/hr

Contract: 2 Years

Location: Fairfield County, Connecticut

Responsibilities :

  • Represent the Pharmaceutical Development department during global regulatory audits and inspections, ensuring compliance and answering all queries.

  • Independently introduce and optimize systems, processes, and training for IMP Delivery teams and leaders, ensuring adherence to industry standards.

  • Lead and manage cross-functional Continuous Process Improvement (CPI) projects, ensuring timely and successful completion.

  • Oversee and monitor archiving activities within IMP Delivery, serving as the main point of contact for archive-related processes and IT systems.

  • Drive innovation and continuous improvement in supply chain processes, identifying and implementing new concepts.

  • Manage deviations, complaints, and CAPAs, ensuring proper documentation and reporting within the Boehringer Ingelheim Quality System.

  • Lead the Risk Management Committee, ensuring risks are assessed, actions are addressed promptly, and audit readiness is maintained.

  • Provide coaching and training on soft skills and the implementation of new and modified processes.

  • Collaborate with cross-functional teams, such as Global Sourcing, GSPC, and Q&RM, to optimize processes across the Pharmaceutical Development department.

  • Maintain the audit and inspection schedule, presenting the risk status and ensuring the department is audit-ready at all times.

Qualifications :

  • Master’s degree in natural sciences, engineering, or related field.

  • 5+ years of experience in business development, project management, or consulting in regulated environments.

  • Strong knowledge of GMP, GCP, HSE, and Six Sigma project management.

  • Proven leadership, excellent communication, and training skills (German and English).

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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