Manager, CMO Quality EMEA fluent in English and German

at  CSL Behring

Reporting to the Head of CMO Quality, the Manager, CMO Quality is responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and to provide quality oversight for outsourced operational activities (e.g. API, Fill/Finish, Packaging). Focus of this QA role is to work on a regional basis (EMEA or Americas) with CMOs, support cross-business unit peers (CSL Behring, CSL Seqirus, CSL Vifor) and cross-functional teams to assure CMO Commercial Readiness (Tech Transfer) and CMO Operations. Core activities include developing and enforcing Quality Agreements, supporting CMO Changes and Deviations, resolving quality issues and reviewing of Quality Performance KPI’s. The Manager may provide on-site support at CMO’s if needed.
This position will represent and lead CSL Quality in Operational/Pre-Campaign Meetings. Relationship management with our key CMO partners is a core responsibility of this role.
This role is Global in nature and this individual will need to collaborate across the Global Quality Team as well as with CMO partners to assure that our Quality Assurance programs are implemented consistently across the network.

MINIMUM QUALIFICATIONS:

• B.S. degree in relevant business or science, or equivalent education and experience.
• Minimum of 5 years’ experience in a GxP environment in the pharmaceutical industry.
• Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
• Strong industry and quality system knowledge (internal and external) experiences within the industry.
• Must be comfortable working in a global, matrix organization.
• Experience in CMO business highly preferred.
• Strong organizational skills.
• Fluent in English and German (written and spoken).

MANAGER: BRANDING RESPONSIBILITIES

• Be a respected manager acting consistent with the overall ESQ partnering strategy and culture.
• Maintains knowledge of new/updated regulations and industry trends and continuously monitors CMO quality and compliance towards those.
• Represent the CMO Q-Oversight function in authority inspections, corporate audits and self-inspections as assigned.
• Perform additional tasks as assigned.