Sr Manager, Quality Assurance

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 fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.

Gilead Sciences, Australia is seeking a knowledgeable and motivated professional capable of working effectively in a cross-functional team environment, as a Senior Manager within our Quality team. The successful candidate will assume a full-time employment as a hybrid head office and working from home.

This role is based in our Melbourne Head Office. Be part of a growing team that values collaboration and fosters an inclusive working environment.  

Key Responsibilities:

• Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and Gilead expectations.
• Manages and maintenance of relevant licenses.
• Manages local process of change control, deviation, CAPA, complaint management and supplier management.
• Manages local Quality Management Review process.
• Participates in Gilead’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
• Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
• Reviews Annual Product Quality Reports (if applicable)
• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Working with 3PL/4PL, provides guidance on supply related issues.
• Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
• Supports the management of quality and distribution complaints.
• Supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction.
• Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.

Knowledge:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.

• Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.

• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.

• Demonstrates keen understanding of Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)

• Demonstrates in-depth knowledge of regional/local regulatory requirements and industry standards.

• Demonstrates excellent verbal, written, and interpersonal communication skills in English.

• Demonstrates knowledge of Information Systems Technology, understanding of Computer Systems Validation (CSV) including current electronic records and signature requirements

• Knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Specific Education & Experience Requirements:

• Bachelors’ degree and 8+ years of relevant experience in a GMP or GDP environment-related field
• Masters’ degree and 6+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work on own initiative as well as display strong teamwork skills.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

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)

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.