Sr Specialist, Quality Systems

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

This role provides QA oversight of the lifecycle Management of all GXP Suppliers and Service providers used by GSIUC involving External audit Management, 3rd Party Investigations, Quality agreement Management, Supplier Qualification's, Supplier notification assessment and Continuous Supplier monitoring

Essential Duties and Job Functions

- Serves as the primary contact for Supplier quality lifecycle management. Oversees the entire supplier lifecycle management of all Gxp suppliers and services providers used by GSIUC including initial qualification, continuous monitoring, periodic evaluation, updates to suppliers, requalification and offboarding
- Coordinates the actions associated with Supplier actions and CAPA, raises and closes supplier corrective actions, supplier complaints and material nonconformances; challenges root cause and verifies CAPA effectiveness.
- Oversees the External audit management programme for GSIUC including conducting or supporting supplier audits
- Oversees the supplier notification assessment process for GSIUC including approval of the SNAs
- Approval of the annual Supplier appraisal report and Excipient Supplier Evaluations
- Serves as QA lead/coordinator for complex internal investigations and CAPA recommendations; may lead compliance audits and interface with regulatory agencies as required.
- Writes or revises controlled documents (e.g. SOPs, specifications) to meet quality objectives and contributes to annual product reviews.
- Represents supplier quality and metrics at regulatory inspections and corporate audits, partners with Procurement and Supply Chain, coach’s colleagues and leads data-driven improvement.
- Ensures ALCOA+ records and inspection-ready eQMS entries compliant with Annex 11 and Part 11.
- Responsible for providing accurate supplier and Quality metrics for Product Quality Reviews and Management Review.

Knowledge, Experience and Skills

Essential

- Bachelor's degree in Life Sciences, Quality, Information Systems, Engineering, Supply Chain or a related discipline; an equivalent combination of education and relevant industry experience may be considered.
- Relevant experience with a BA/BS (or 4+ years with an MS) in pharmaceutical, biotechnology, medical device or other regulated manufacturing.
- Strong knowledge of cGMP, pharmaceutical quality systems and EU/FDA supplier and material control requirements.
- Significant supplier quality experience, including Supplier investigations and CAPAs
- , audits, Quality Agreements and supplier change notifications, as well as supplier deviations, CAPA and change control.
- Proven ability to analyse and present Quality KPIs and trends that drive action, applying Quality Risk Management to complex decisions.
- Strong root-cause analysis, problem-solving and technical writing skills.
- Excellent communication and influencing skills with cross-functional stakeholders, including Quality, Supply Chain, IT and Business Operations.
- Works independently with wide latitude, manages multiple projects and priorities, is recognised as a QA resource and mentors less experienced colleagues.

Desirable

- Lead auditor qualification; experience auditing material suppliers e.g excipient or packaging suppliers.
- Knowledge of computerised system compliance (21 CFR Part 11, validation principles) and experience supporting eQMS or business system enhancements.
- Lean/OPEX or Six Sigma (DMAIC) methodologies, and risk tools such as FMEA or HACCP.

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 individual’s 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.