Sr Tech Advisor - Global Quality, Compliance & External Collatoration

Job description

·  Job facts

Job Summary:

Conducts and supports external interactions, policy and strategy activities as they relate to key Quality activities including global inspection and compliance. Coordinates comments on GMP/GDP related external documents. Manages information regarding external regulations and trends for /input feedback with SMEs throughout the PT organization. Supports liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees.

Job Responsibilities:

·  Participates as a key member of teams or committees throughout the global PTQ organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance.
·  Support the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.
·  Develop and maintain relationships with industry and regulatory bodies in specific regulatory regions of the world assigned, with specialized expertise in requirements and trends in that region, while being aware of global effects and strategies as they affect Quality and Compliance
·  Establish and maintain strong, effective positions within key industry/trade organizations including technical task teams, groups or through written media, e.g. technical articles to influence industry positions on key strategic Quality topics
·  Provide up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization
·  Contribute to formal written communications within the PTQ organization updating on the regulatory environment
·  Contribute to PTQ regulatory , quality and CMC strategies based upon latest regulatory and technical trends derived from industry and regulator interactions and communications
·  Coordinates with SMEs throughout the PTQ organization to understand their needs, work with outside bodies to influence on these and to engage SMEs in regulatory and industry interactions , meeting and committees including technical journals and other media to influence and collaborate on technical and regulatory issues

Job Requirements/Qualifications:

·  Bachelor's or advanced degree in related technical area with 10+ years experience in regulatory, quality or process development
·  Certification or training in quality and technical areas is desirable e.g. ASQ. ,continuing education or in house training
·  Proven ability to be part of a team responsible for the execution of successful innovative GMP and CMC regulatory strategies in the areas of Quality and Compliance
·  Proven ability to communicate and interact with global health authorities
·  Expert in the area of Quality and Compliance including primarily GMP/GDP and also CMC issues
·  Experience with manufacturing, analytical, compliance, and regulatory issues including knowledge of quality systems, quality risk management and their relationship to manufacturing
·  Prior industrial or regulatory agency experience including leadership roles in applying quality systems to the manufacture of pharmaceuticals through various lifecycle stages
·  Interaction with industry and professional organizations in manufacturing quality areas to include participation or leading workgroups and giving presentations.

*Travel required approximately 30 percent.

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Roche is an equal opportunity employer.
Quality, Quality > Quality Systems

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.