Quality Assurance Specialist - ESO Quality Control

The QA Specialist – ESO Quality Control (QC) provides Quality Assurance oversight of all QC-related activities performed within the External Supply Organization (ESO), contract laboratories, and API suppliers on behalf of the principal contract giver. The role ensures full compliance with international GMP requirements applicable to both small molecules and biotechnology products.

Scope of responsibilities:

• Implement and execute QA oversight strategies for External Contract QC Laboratories, ensuring consistency, performance, and compliance of operations.
• When applicable, act as the accountable QA supporting industrial technology transfer activities (MSAT projects).
• Ensure robust management of product quality processes in alignment with internal quality standards and regulatory expectations.
• Maintain accurate, complete, and up-to-date documentation related to all QA activities within scope.

In this role, the QA Specialist may also be responsible for budget monitoring related to QC oversight activities and will regularly collaborate cross-functionally to ensure timely and complete execution of responsibilities.

The QA Specialist needs to ensure that all QC-related activities are performed in full compliance with applicable Good Manufacturing Practices (GMP), as well as national and international regulatory requirements, thereby safeguarding product quality and patient safety.

• QA Oversight & External QC Management
  • Provide QA oversight for all QC activities performed by ESOs, contract laboratories, and API suppliers.
  • Establish and maintain governance and interaction models with external partners, including KPI monitoring.
  • Participate in the qualification and evaluation of ESOs, contract laboratories, and API suppliers.
• Quality Events & QMS Management
  1. Oversee QC investigations (OOS, OOT, OOE), ensuring proper documentation, timely execution, and closure.
  2. Ensure effective management and follow-up of associated CAPAs.
  3. Manage Change Controls related to external QC activities within the QMS.
• Product Quality & Data Integrity
  • Contribute to APQR/PQR programs in collaboration with external partners.
  • Manage product stability programs and monitor trends.
  • Ensure QC data integrity, including completeness, traceability, and scientific relevance.
  • Perform or oversee data trending and statistical analysis.
• Governance & Performance Monitoring
  • Participate in quality governance forums (e.g., QMRs, periodic reviews).
  • Monitor and report on the performance of external QC activities.
  • Support budget tracking related to ESO QC activities (as applicable).
• Technology Transfer Support (MSAT)
  • Act as QA representative for industrial technology transfers.
  • Review and approve QA documentation (e.g., validation protocols and reports).
  • Oversee analytical method lifecycle, including validation, verification, and transfer in line with ICH guidelines.
• Audits, Inspections & Compliance
  • Participate in and/or lead internal and external GMP audits.
  • Ensure follow-up and closure of audit CAPAs.
  • Support preparation and management of regulatory inspections.
• Cross-functional Collaboration & Continuous Improvement
  • Collaborate with internal stakeholders (MSAT, Regulatory Affairs, Supply, QP, etc.) and external partners.
  • Drive continuous improvement of QA/QC processes.
  • Ensure alignment of QC activities with regulatory filings and requirements.

• Collaboration & Teamwork:
  • Ability to work effectively across functions and in a multicultural, international environment, fostering strong collaboration with internal and external stakeholders.
• Leadership & Influence
  • Demonstrates leadership in interactions with peers, subordinates, and management; able to influence decision-making and drive alignment.
• Communication Skills
  • Communicates clearly and effectively, both verbally and in writing, ensuring understanding of quality requirements, issues, and decisions.
• Decision-Making & Problem-Solving
  • Facilitates sound decision-making and applies structured problem-solving approaches in a quality and compliance-driven environment.
• Continuous Learning & Knowledge Sharing
  • Actively develops expertise, stays up to date with industry practices, and shares knowledge with colleagues
• Organizational Awareness
  • Demonstrates understanding of organizational structure, functions, and cross-functional interactions.
• Adaptability & Regulatory Awareness
  • Maintains compliance with evolving regulatory requirements and adapts to changing environments and expectations.
• Autonomy & Accountability
  • Works independently with a high level of ownership and accountability for deliverables and outcomes.