Full-time Onsite

Direct Hire

Job Summary

Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight. Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.

Area of Responsibility

• Review of manufacturing and packaging records
• Review certificate of analysis and Certificate of compliance
• Ensure the release packages are ready prior to batch disposition
• Review of QMS records submitted by CMO and monitoring (e.g. change controls/deviations, quality agreements but not limited to)
• Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
• Actively participate in day to day meetings
• Participate in the qualification process and support assigned CMO aligned with the Pharma Quality Management Systems and provide reports as required.
• Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
• Implement and maintain Regional CMO data in the Global CMO database.
• Ensure the Quality Assurance Agreements which are created and maintained according to Pharma requirements, are regularly reviewed and followed.
• Conduct review and approve batch release documentation.
• Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
• Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
• Manage and oversee complaint module for the Site.

Travel Estimate: Up to 10 %

Education and Job Qualification

• Minimum of a Bachelor’s degree in a scientific discipline; MS preferred.
• Certified Quality Auditor (e.g. ASQ) certification preferred.
• Minimum of five (05) years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries.
• Expert skills related to investigations (e.g. Lean Six Sigma) Quality Agreements, and CMO management.
• Ability to identify key priorities necessary for and be able to author/implement global policies and procedures.
• Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools.
• Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory requirements).
• Strong interpersonal and communication, both written and verbal, skills.
• Good negotiation and influencing skills.
• Operational knowledge of pharmaceutical processing and packaging operations.
• Task oriented team plan who is able to manage multiple complex priorities and work in a cross-cultural working environment.
• The requirement for English language proficiency for this job role is Intermediate-B1 (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). Experience