Associate Director Regulatory & Start-up (based in Bratislava)

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com

RESPONSIBILITIES

 Assist in formulation of strategic initiatives and work with functional management to develop implementation plans, including regulatory and start-up evaluation measures.

 Interface with internal contacts to determine operational strategy and/or expectations and parameters for key deliverables.

 Provide Proposal Management with input on proposals and budget development for regulatory and start-up components of projects. Attend proposal defences as needed.

 Liaise with clients to ensure operational efficiency; implement updates to processes to ensure maximum efficiency and customer satisfaction.

 Review and analyze performance metrics and processes to provide input in the development and implementation of process/system improvements.

 Accountable for employee departmental efficiency and adherence to standard operating procedures (SOPs), Work Instructions, and project instructions and timelines.

 Manage employees in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning and directing work of employees; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.

 Assist with audits and provide recommendations and assist in the implementation of Corrective Action Plans.

 Resource employees efficiently to ensure achievement of utilisation and realisation targets.

 Manage the selection and on-boarding process for new employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities.

 Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams.