QA Compliance Expert - Reg CMC Facilitator

• Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date.
• Conducting training to ensure appropriate knowledge and regulatory compliance.
• Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis products and customer products.
• Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle.
• Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits.
• Implementation and overview of initiatives to improve (regulatory) compliance.
• Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products.

Essential Requirements:

• Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent.
• Fluent English (German desired).
• More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids.
• Ability to speak up and to take Quality decisions during challenging situations.

Desirable Requirements:

• Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience.
• Ability to work independently and effectively in international, complex, and multifaceted environments.