Head of Quality Assurance Europe ARIAD Pharmaceuticals, Inc. - Lausanne

Summary

Establish, develop and lead the Quality Assurance (QA) function at ARIAD Pharmaceuticals (Europe) Sárl.

Duties and Responsibilities

• Build and maintain ARIAD’s QA presence in Switzerland and Europe in support of product launch and distribution
• Oversee the GMP/GDP activities of contract manufacturing organizations (CMO) and distribution partners in Europe
• Oversee and direct the activities of multiple contract RP and QA consultants, supporting ARIAD’s manufacturing, licensing and distribution of Drug product in Europe
• Provide QA oversight of:
  • Oral Drug Product manufacturing at manufacturers
  • Supply and Distribution to Customers
  • Recall service providers
  • Provision of Medical Information
  • Control of Responsible Marketing & Promotion
  • Manufacturing from API through to finished packed and EU release tested product and QP release of product to market
  • Accounting for technical & scientific progress
  • Support complaints & recall in Switzerland and Europe in partnership with the Person Responsible per the MAA
  • Interact with Regulatory Authorities in Switzerland and Europe in cooperation Regulatory Affairs
  • Host EMA and local authority inspection of the European QMS and related procedures
  • Prepare  ARIAD Europe for audit readiness and host the Regulatory Agency audits
  • Track and communicate Quality Defects
  • Work closely with Corporate Quality Management to implement all activities in coordination with the ARIAD manufacturing and supply chain business partners
  • Be responsible for the management of, and compliance with approved procedures governing all activities under the responsibility of the MAH
  • Audit of the various third parties and ARIAD functions to ensure compliance with the MA and regulatory requirements
  • Create and implement all GMP/GDP related awareness programs and/or training across ARIAD Europe
  • Management of the CH and EU SOPs in ARIAD’s electronic documentation database

Requirements

• BSc in Biological, Chemical or Medical sciences (or related area), MS preferred.
• Minimum of 10 f experience in progressively greater areas of responsibility as relates to QA and Quality Management in a Pharmaceutical or Biotech company in Europe.
• Experience in managing QA staff in a fast-paced and cross-functional environment
• Experience in Managing Quality at CMOs and other QA-related Service providers (Distributors, Consultants, Test Labs, etc.)
• A proven track record in applying Risk-Based and Science-based thinking towards resolving quality issues and towards maintaining and improving quality systems
• Fluency in English is mandatory; Fluency in French and/or German is a strong

Company Description

ARIAD Pharmaceuticals, Inc (NASDAQ: ARIA) is a pharmaceutical company whose vision is to develop new, breakthrough therapies with the potential to transform the lives of patients with difficult-to-treat cancers.

ARIAD is a global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).