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Job Description - Manager/Senior Manager, Clinical Quality Assurance

Description: We are looking for a motivated individual with the professionalism and sensitivity to successfully interact with diverse individuals. Responsible for assuring those clinical research activities undertaken by OXiGENE in the region responsible are conducted in compliance with all applicable Regulatory and contractual requirements. Management of the activities of internal and/or external auditors within the GCP-QA area. Development and provision of input into functional processes for area managed in support of strategic goals. Serving as a high level technical contributor within the GCP-QA area.

Specific duties include:

• Defines schedules and work plans for selecting, monitoring, and overseeing audit activities that are consistent with overall audit strategy and company goals.
• Directs GCP-QA audit activities to deliver timely feedback to Senior Management to enable achievement of Company strategic objectives and goals across functional areas within Global development project teams and across commercial functions within the business.
• Delegates tasks and allocates resources within work plans and provides GCP-QA direction to internal auditors and/or external contractors/vendors
• Contributes to developing and applying new approaches for audit tracking and trending to enable (or provide) feedback into the Quality System
• Contributes to the modification, development and implementation of company practices and policies for GCP-QA
• Supports the regulatory inspection activities
• Establishes a network of relationships with key international Quality Assurance professionals
• Directs identification of compliance issues through the use of internal and external audit programs that minimize regulatory and business risk
• Provides broad scientific leadership and advice to Global Development personnel related to a specific area of GCP-QA
• Coaches, mentors, and advises internal and/or external auditors.
• Responsible for negotiation in varied situations and at the highest levels, both internally and externally, in order to reach appropriate resolution

Technical Knowledge:

• Develops and demonstrates recognized levels of experience working in related areas of GCP-QA
• Maintains extensive knowledge of all relevant Oxigene technologies and processes. Demonstrates expert knowledge of GCP, National and International regulations, directives and guidelines (European, International and FDA)
• Maintains and applies awareness and understanding of the impact of compliance issues within the context of Oxigene Global Development and the external pharmaceutical industry
• Maintains a broad level of awareness of Global Development
• Represents Oxigene externally and contributes to industry forums, as required

Requirements: The successful candidate will have excellent interpersonal, verbal, and written communication skills, a flexible attitude with respect to work assignments, and new learning. Will have the ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills and must be proficient with computer (MS Office) and internet skills. Foreign language is a plus. Up to 25% travel required.

8+ years relevant regulatory pharmaceutical experience, including 4 years of management experience, extensive knowledge of all aspects of the Global Development process and successful management of a Global development function comprising of internal and contracted employees. College degree required, preferably in a technical/scientific discipline.

To apply, please send your resume and cover letter to jobs@oxigene.com.