Senior Manager - Quality Assurance Kite at Gilead Sciences

Melbourne, Victoria, Australia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Highly experienced and motivated individual
Experience working cross-functionally with Quality, Commercial, Regulatory, Supply Chain, and Medical Affairs
Ability to lead a multi-market organization in ANZ and other APAC regions as needed
Expertise in implementing and ensuring qualification and monitoring programs for hospital apheresis centers and treatment sites
Knowledge of product complaints investigations
Experience with global labeling capabilities and Responsible Person (RP) responsibilities in ANZ and APAC
Ability to represent QA in regional leadership teams and with external partners

Responsibilities

Establish, execute, and manage the qualification process for new and established apheresis centers and treatment sites (ACTS) using risk-based tools for qualification, training, and monitoring
Collaborate with Global Site Qualification to determine strategy for maturing the ongoing program, sustainability, and compliance to regulatory changes
Collaborate with cross-functional departments to ensure timely implementation of quality processes
Provide leadership and direction in the industry on site qualification processes and management
Assess and approve changes to courier tracking and order intake systems to maintain validated state
Lead Quality’s collaboration with Commercial for start-up and routine management of ATCS relationships and with Supply Chain to ensure compliance across the Kite product journey and best customer experience
Implement, assess, and report on metrics monitoring per schedule and provide updates to approved ATC list
Assure business systems are developed, supported, and maintained in a validated state for patient traceability
Act as Quality contact (or delegate) for ATCS issues and discrepancies, and lead/manage investigations to resolve them
Interact with regional leadership teams and external partners representing Kite QA

Skills

Quality Assurance

Product Quality

Distribution Quality

Regulatory Affairs

Commercial Operations

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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