Senior Manager, Packaging Operations
Senior Manager, Packaging Operations
Ireland - Cork
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Responsible for contributing to the technical management and oversight of multiple commercial pharmaceutical packaging projects, in the following ways:
- Oversees and contributes to the completion of all technical and operational packaging activities both locally and globally, to ensure commercial product supply is maintained through management and prioritization of internal and external resources.
- Leads activities for manufacturing sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for limited-scope projects.
- Directs activities within the group to meet company goals including production schedules, budgeting, training and performance reviews.
- Manages complex processes across functions and interacts effectively with the other team members to ensure packaging systems meet regulatory, performance and cost requirements.
- Responsible for initiating and directing the implementation of packaging changes and new packaging introductions on multiple projects across multiple production sites, in line with corporate goals and objectives.
- Coordinates equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes, reviews and/or approves qualification/validation/technical reports.
- Ensures all packaging documentation (Specifications, Master Production Records, Worksheets, etc.) is completed in a timely and accurate manner.
- Generates and maintains Learning Plans and Training Modules. Trains new employees in SOPs and documentation systems.
- Provides technical guidance and training to stakeholder and personnel impacted by the introduction of new systems.
- Leads technical investigations and assessment of deviations and CAPA's
- Contributes to the development of department strategies.
- Responsible for tracking and updating senior management on the project execution status and providing updates on potential challenges and their resolution.
Qualification and Skills Required:
- BS or MS degree in Engineering or Science field, preferably in Chemical Engineering, Pharmaceutical Sciences/Engineering or Mechanical Engineering.
- Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents. (i.e. SUPAC, PACPAC).
- Demonstrates ability to direct and implement technical/electronic solutions for supporting packaging operations systems (i.e. software, hardware, data analytics, inspection systems).
- Motivated individual, who can work independently, with effective planning and prioritization skills.
- Excellent analytical/ problem solving skills.
- Excellent verbal, written, and interpersonal communication skills, with experience writing technical reports.
- Demonstrates strong computer, organizational, and project management skills required.
- Ability to function well in small technical groups in a dynamic, fast-paced work environment, working on multiple, time-sensitive projects.
- Significant experience in the pharmaceutical industry and a BS , BA or MS.
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 log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Ireland---Cork/Senior-Manager--Packaging-Operations_R0015299
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