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).
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).
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