Beschreibung

As an External Manufacturing Manager, you will play a vital role in managing relationships with contract manufacturers and laboratories, ensuring the timely delivery of high-quality medicines while collaborating with cross-functional teams to drive operational excellence.

Anforderungen

• •University degree in Manufacturing, Supply Chain, or relevant field
• •Minimum 5 years’ experience in pharmaceutical or life science industry
• •At least 2 years’ experience in coordinating roles, including project management
• •Hands-on experience with digital systems and good knowledge of MS Office
• •Previous experience working directly with CMOs, CLOs, or external partners
• •Strong understanding of cGMP manufacturing of biologics and/or small-molecule pharmaceuticals
• •Ability to thrive in a cross-functional, matrixed, and global environment
• •Excellent verbal and written English communication skills
• •Excellent verbal and written Swedish
• •Verbal and written skills in Chinese or Japanese is highly desired
• •Negotiation skills

Aufgaben

• •Lead cross-functional Virtual Plant Teams
• •Act as the main point of contact for assigned CMOs and CLOs
• •Drive strategic and operational management of CMOs and CLOs
• •Conduct Business Reviews and Operational Meetings
• •Manage supplier relationships and ensure compliance with supply agreements
• •Oversee change orders and improvements for OTIF delivery
• •Participate in sourcing and evaluating new contract manufacturers
• •Develop supply and quality agreements
• •Contribute to internal activities related to external manufacturing
• •Manage change management and critical deviations
• •Oversee CAPAs and related processes
• •Issue, review, and approve relevant SOPs and manufacturing instructions
• •Review applicable sections of APR and PQR
• •Provide budget input for CMO and CLO-related costs
• •Ensure adherence to budget for external manufacturing activities

Tools & Technologien

Benefits