Job Purpose
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.
* Act as the accountable QA supporting industrial technology transfer activities (MSAT projects) when applicable.
* 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 must 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.
Key Responsibilities
- 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
- Oversee QC investigations (OOS, OOT, OOE), ensuring proper documentation, timely execution, and closure.
- Ensure effective management and follow-up of associated CAPAs.
- 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 (QMRs, periodic reviews).
- Monitor and report on the performance of external QC activities.
- Support budget tracking related to ESO QC activities (as applicable).
- 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.
* Act as QA representative for industrial technology transfers.
* Review and approve QA documentation (validation protocols and reports).
* Oversee analytical method lifecycle, including validation, verification, and transfer in line with ICH guidelines.
Required Education
Master's degree (MSc), PharmD, or Engineering degree in a relevant scientific field.
Required Skills and Experience
* 8+ years GMP QC/QA experience with external manufacturing exposure.
* Strong expertise in GMP Quality Assurance and Quality Control, including oversight of external manufacturing and contract laboratories.
* In-depth knowledge of QC processes: OOS/OOT/OOE investigations, CAPA management, and Change Control within a QMS.
* Solid understanding of data integrity principles, QC data trending, and statistical analysis.
* Experience with product quality processes such as APQR/PQR and stability program management.
* Expertise in analytical method lifecycle management (validation, verification, transfer) in line with ICH guidelines.
* Strong knowledge of international GMP requirements and regulatory frameworks for pharmaceuticals (small molecules and/or biologics).
* Experience with audits (internal/external) and support of regulatory inspections.
Required Behaviours and Competencies
* Ability to work effectively across functions and in a multicultural, international environment.
* 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.
* Decision‐Making & Problem‐Solving: Applies structured problem‐solving approaches in a quality and compliance‐driven environment.
* Organizational Awareness: Demonstrates understanding of organizational structure, functions, and cross‐functional interactions.
* Adaptability & Regulatory Awareness: Maintains compliance with evolving regulatory requirements.
* Autonomy & Accountability: Works independently with a high level of ownership and accountability for deliverables and outcomes.
Required Languages
- Very good knowledge and level of English/French (written and spoken)
Travel required in %
20%
Equal Opportunity
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
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