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
Job Posting Details Packaging Documentation Specialist (Grade 26/27)
Description:
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.
The Position:
Packaging Documentation and System Specialist is an exciting opportunity to become part of the Global Packaging, Labelling & Digital Manufacturing Capabilities (PLDMC) organization at Gilead. The Packaging Documentation specialist shall be primarily responsible to lead GMP packaging documentation, Packaging Systems and Workflow management for multiple Gilead products across the Gilead External Packaging network. The specialist shall also be responsible for designing and conducting package testing in close coordination with Global Packaging Engineers. Based on business requirements, Packaging documentation specialist may be required to provide technical and packaging & labelling system integration support to Contract Manufacturing Partners (CMOs) globally and to contribute to the development of the internal and external packaging capabilities.
Job Responsibilities:
GMP documentation and packaging systems expertise to efficiently manage change controls, packaging & labelling specifications, technical documentation/reports etc.
Ensures that all documents are technically and mechanically accurate, consistent with internal style guidelines, and consistent regarding clarity, flow, organization, completeness, accuracy, readability, and/or appropriateness.
Position requires basic technical knowledge of packaging materials, processes, qualification & validation requirements in high volume manufacturing set up.
Stakeholder management - to work closely with multiple internal and external stakeholders including Quality, Validation, Regulatory, Labelling Operations, Supply Chain, CMO Management and Packaging Suppliers.
With minimal guidance, determines the functions most critical to departmental success and supports priorities accordingly.
Design and conduct package testing and transportation studies for multiple pack formats. Ex: bottle pack, glass vials pack etc.
Analyze packaging engineering processes and documentation practices to identify and implement continuous improvement initiatives.
Facilitates the review and approval process and liaises with the business process owner to ensure the document intent is achieved.
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Works with manufacturing sites to define requirements for master batch records.
Interfaces with Packaging Engineers & Vendors to develop alternate designs of packaging components and translate into actionable specs.
Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Supports technical investigations and deviations.
Ensures that QMS Records are managed and closed out in a timely manner.
Supports the preparation of documents for Regulatory filings.
Performs other related duties and assignments as required to meet dynamic business needs.
Knowledge, Experience and Skills:
Degree in Packaging, Supply Chain, Quality, or related field is essential.
Demonstrates excellent verbal, written, and interpersonal communication skills.
Demonstrates knowledge of Good Manufacturing Practice (FDA, EMA and ICH) and Quality Systems, with the ability to independently assess compliance risks.
Demonstrates strong knowledge of cGMP & regulatory processes.
Demonstrates knowledge of quality assurance systems, methods, and procedures.
Experience with Electronic Document Management Systems or other GXP application is preferable.
An understanding of Packaging Lifecycle Management software/systems to manage documentation workflow is an advantage.
Experience of primary and secondary packaging and labelling processes, device and kitting assembly process, qualification/validation requirements is an advantage.
Project Management experience is an advantage.
Technical writing experience in the biotech or pharmaceutical industry is beneficial.
Behaviors
Ability to engage and partner with multiple stakeholders to achieve the objective.
Curious with learning agility.
Operationally excellent.
Organized with systematic approach to prioritization.
Process orientated to achieve the business objectives.
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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.