Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.
The Position
This role is a QA Specialist II, permanent role in the GSIUC QA Department, under the QA Supplier systems group. This specific role is required for QA oversight for all GXP Suppliers and Service providers involving External audit Management, QAG Management, External Deviation ownership, approval and coordination, local supplier management involving qualification, approval, and monitoring.
Essential Duties and Job Functions:
* Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
* Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers i.e change control.
* Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.
* Approval of new supplier and material part numbers within Gilead's product lifecycle management system.
* Periodic Evaluation/Continuous monitoring of approved Suppliers/Service provider.
* Review of approval of Supplier appraisal reports.
* External Audit Management.
* Quality agreement Management.
* Approval of External Deviations associated with Suppliers/Service providers including full supplier investigations and tracking/trending supplier/material issues.
* Coordination of External Deviations associated with Cxo's.
* Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review.
* Assessment and Approval of Supplier/Service provider Notifications including changes and quality issues.
* External and Internal auditing.
* Support for regulatory and corporate audits.
* Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
* Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
* Review and approval of GMP Deviation investigations and CAPAs if required.
* Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
* Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
Knowledge, Experience and Skills:
* Prior experience in pharmaceutical industry is preferred (ideally within a QA role).
* Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems).
* Demonstrates working knowledge of quality assurance systems, methods, and procedures.
* Good verbal, written, and interpersonal communication skills.
* Proficiency in Microsoft Office applications.
Typical Education & Experience:
Relevant experience in a GMP environment related field and a BS or MS.
Behaviours:
* Positive attitude and enjoys working as part of a team.
* Resilient profile with the ability to deliver in a challenging environment.
* Ability to engage and manage multiple stakeholders to achieve the objective.
* Curious with learning agility.
* Operationally excellent.
* Organised with systematic approach to prioritisation.
* Process orientated to achieve the business objective.
Gilead Core Values:
* Integrity (always doing the right thing).
* Teamwork (collaborating in good faith).
* Excellence (working at a high level of commitment and capability).
* Accountability (taking personal responsibility).
Estimated salary: $80,000 - $110,000 per year, based on location and industry standards.