Quality Operations Manager

My client is a CMO-based pharmaceutical group seeking to hire a Third Party Manufacturing Quality Operations Manager to oversee the management of relationships with external suppliers and manufacturing sites.

The key responsibilities of the position will include:

• Manage the relationships between the client and TPM organisations with respect to quality
• Maintaining quality oversight of solid dose and sterile manufacturing operations
• Support EMEA-wide quality operations where required on behalf of the client
• Engage with the Manufacturing and Technical Services Departments where required on all matters pertaining to product quality
• Development of quality department processes for Annual PQRs, RFTs, and review/approval of quality agreements
• Be the group quality representative for all technical transfer projects
• Act as back up to the QP on quality matters and batch approval where necessary

The successful applicant, aside from having extensive experience in a senior quality capacity within the pharmaceutical industry, will have the following experience and expertise:

• In depth knowledge of the solid dose manufacturing process, coupled with extensive exposure to sterile manufacturing.
• Strong quality systems management experience.
• Extensive experience with CMO-based quality systems
• Management of complex technical agreements with suppliers and TPMs
• Knowledge of all facets of quality, including validation, manufacturing review, packaging and supply chain