QA Specialist II

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

QA Specialist II position in QA Supplier Systems Group Gilead Sciences Ireland UC Cork

Gilead Sciences Inc. is a research-based biopharmaceutical company that discovers develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS liver diseases cancer and inflammation and serious respiratory and cardiovascular conditions.

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 used by GSIUC involving External audit Management External Deviations Quality agreement Management Supplier introduction approval Supplier notification assessment and Continuous Supplier monitoring.

This position requires a sound knowledge of quality assurance systems methods and procedures. The candidate will be required to exercise judgment within well-defined and established procedures and practices to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.

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.

• 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 Gileads 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

• External Deviation approval

• Completion of yearly Excipient Supplier evaluation including completion of audit frequency assessment and GMP criticality gap assessment review

• Ownership 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.

• Normally receives very little instruction on routine work general instructions on new assignments.

Knowledge Experience and Skills:

• Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.

• Experience with working with external suppliers is preferred and ability to act when quality issues are seen.

• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)

• Demonstrates working knowledge of quality assurance systems methods and procedures.

• Basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.

• Demonstrates audit and investigation skills and report writing skills.

• 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

• Operationallyexcellent

• 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)

• Inclusion (encouraging diversity)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.