Interim CMC Quality Assurance Specialist

Responsabilities and main tasks:

• Provide support to the CMC Department in Good Manufacturing Practices (GMPs) with significant operational and quality experience
• Drive process and product quality through CMC quality systems, ensuring adequate supplier oversight/surveillance
• Document and initiate change control, perform quality investigation reports in company´s quality management system
• Provide strategic planning input and continual improvement measures focused on records processes, reporting/escalating critical quality issues
• Manage, maintain, and continuously improve the batch review process as a facilitator for Quality Assurance in product teams
• Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to quality and error reduction
• Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality
• Perform additional quality-related duties as assigned by Director CMC Operations

Whom we are looking for:

• An MSc. in one of the following areas: Biochemistry, Biotechnology, Chemistry, Chemical Engineering or similar
• More than five years of experience in quality assurance in drug development and commercial manufacturing in the biopharmaceutical industry
• Solid GMP-regulated experience working in GMP quality systems and with drug substances and drug products; clinical and commercial experience in a GMP environment preferred
• Experience interacting with the FDA, EMA and other global health authorities
• Excellent verbal and written communication and presentation skills in English, preferably also in Swedish
• Strong analytical and organisational skills, with attention to detail
• Excellent written, verbal, listening and interpersonal communication skills
• Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
• Ability to take initiative, prioritise and execute tasks with minimal direction or supervision, maintaining a high level of confidentiality, integrity and discretion at all times

The process:

The assignment is expected to start as soon as possible and will go on for 10 months full-time.

Are you available and have the right background? Apply today!

Responsible recruitment consultant is Lena Arrelöv and researcher Hedda Tornert.