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Mylan

Snr. Manager, Global Quality Training EMEA

Mylan

  • Dublin
  • Negotiable
  • Permanent full-time
  • Updated 06/03/2013
  • HR
this job is expired
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Description

Snr. Manager, Global Quality Training EMEA for Pharmaceutical Company

 

Title: Snr. Manager, Global Quality Training EMEA

Reports To: Director Global Quality Systems - Training

A brief summary of the purpose this position must fulfill. 

This position will  provide leadership, support and direct engagement in  the development of a standardized methodology for GMP training systems throughout Mylan.  The successful candidate must maintain current knowledge of new and/or revised regulations and industry best practices; collaborate with other quality functions as necessary; oversee process design and process improvement initiatives towards achieving integrated, streamlined and efficient global processes and SOPs and training; manage departmental priorities and work closely with senior leadership; collaborate to ensure adequate administration and oversight of Quality Learning Management System (LMS), and provide direction towards the development and standardization of training processes

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

  • Assess current practices and procedures for site-based training and training programs in the Mylan network.
  • Identify key site contacts and establish teams at sites worldwide to cooperate in the development of a standardized training model.
  • Develop standardized training program model .
  • Develop standardized curricula in collaboration with senior leadership, support training design and oversee training assignments.
  • Develop strategies to ensure adequate collaboration and communications towards the appropriate management of SOPs, processes and training.
  • Foster cooperation and improve working relationships within Quality  by responding to issues and concerns, providing solutions, guidance and support consistent with company policy with respect to training programs. This may include assessment of current processes, review of audit and inspection reports in order to identify gaps and process improvement opportunities, recommend solutions for process improvement and course of action to address issues identified.
  • Drive process improvement initiatives by collaborating and communicating with peers and relevant functions.
  • Develop and implement communication plans designed to provide clarifications on the interpretation of regulations,  perform assessment of existing process and training needs and recommend solutions for issue remediation, as necessary.
  • Identify, recommend and implement, as agreed with management, appropriate tools and technology to support training.
  • Develop and report metrics to reflect activity progress and status of compliance in SOP and training-related activities.
  • Consults with functions outside of Quality as necessary, to accomplish assigned responsibilities.
  • Serve as global subject matter expert for standardized training issues.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

 KNOWLEDGE 

Must possess in-depth knowledge of all major regulatory  requirements includingU.S., E.U., Australian, Japanese, WHO, PIC/S, and ICH regulations and guidances.  Must be knowledgeable of cGMP trends and industry direction. 

SKILLS AND ABILITIES

Experience in instructional design, education, training or equivalent expertise is required. Effective written and oral communication, collaboration/negotiation skills and proven record of being an effective team player are required. Knowledge of and direct experience with a LMS system is required.

 SUPERVISION

Position functions semi-autonomously. 

 EDUCATION/EXPERIENCE

Minimum of a Bachelor's degree (or equivalent) and 5 years of experience is required. 10 years experience in pharmaceutical industry with 8 years in a quality role is preferred. However, a combination of experience and/or education will be taken into consideration. 

 

Ref: Sr. Manager, Global Quality Training EMEA
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Mylan

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