Senior Quality Officer/Specialist

Conteúdo do emprego

Department:

Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight

of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and

business partners involved in the manufacture, testing, and transport of our client’s products. SCES Q staff interact with functional units within Specialty Care Quality (SCQ), other sites, and other

organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure

compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API,

drug substance) and finished products with minimal risk to quality or product supply.

SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases

and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.

Key Responsibilities;

• The SCES Q Contract Manufacturing Quality Specialist acts as the day-to-day liaison with internal and external customers for quality related activities.
• Ensure GMP compliance of products manufactured and/or tested at a contract facility.
• Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
• Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
• Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet internal and GMP requirements.
• Contribute to the completion of milestones associated with specific projects.
• Release product in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).
• Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
• Provide guidance to less experienced staff, as applicable.

Requirements:

• Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include 3 years in a Quality role
• Excellent communication and organizational skills.
• Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).
• Regular travelling