Quality Systems Specialist III

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

The Position

This role is a QA Specialist III/ Trainee QP permanent role in the GSIUC QA Department. The successful candidate will be required to perform QA review and approval of documents procedures changes qualifications and GMP deviations. It is expected that the candidate will progress in the role with an ultimate aim of releasing batches. This position requires a sound knowledge of quality assurance systems methods and procedures. The candidate will be required to exercise judgment 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.

Job Responsibilities:

• Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.

• Certifies batches for sale or supply in compliance with regulations

• Perform advanced batch record reviews and compile batch release documentation for QP review.

• Assess deviations OOS/OOT investigations and CAPAs for potential impact on product quality; prepare risk assessments and QP decision summaries.

• Review and approve change controls with focus on regulatory and Marketing Authorization (MA) impact; escalate complex changes to QP.

• Evaluating qualification and validation documentation for manufacturing and packaging processes.

• Participate in supplier qualification activities and review critical material documentation (e.g. CoAs TSE/BSE statements nitrosamine risk assessments).

• Assist in preparing for regulatory inspections and audits; draft responses and maintain compliance evidence packs.

• Contribute to Product Quality Reviews (PQR) and trend analysis for complaints deviations and stability data.

• Maintain current knowledge of EU GMP Annex 16 and QP responsibilities; complete structured QP training program and maintain logbook.

• Represent QA in cross-functional meetings and support decision-making for complex quality issues under QP supervision.

Knowledge and Skills:

• Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Proficient in application of QA principles concepts industry practices and standards.

• Demonstrates ability to effectively manage multiple projects/priorities.

• Proven analytical and conceptual skills.

• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.

• Demonstrates audit and investigation skills and report writing skills.

• Demonstrates excellent verbal communication technical writing and interpersonal skills.

• Demonstrates working knowledge with good proficiency in Microsoft Office applications.

• Knowledge of Six Sigma Define-Measure-Analyse-Improve-Control (DMAIC) methodology performance measures and quality improvement

• Working knowledge of risk management tools (e.g. Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Typical Education & Experience:

• Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
• Extensive experience in the pharmaceutical industry and a BS/ BA 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.