Senior Specialist, Quality Systems and Compliance - Netherlands
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.
- Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- One of the essential building blocks of our manufacturing division’s Back to Basics (BtB) strategy is the Quality Systems Improvement Program (QSIP).
- This is a multi-year program
- to retool our manufacturing division’s Quality Management System and is critical to the successful execution of the BtB program.
- Positions to support the QSIP initiative are highly coveted within the Quality Organization because they represent the challenging opportunity to focus on improving business processes and compliance posture of the company while continuing to run the business.
This Senior Specialist position within the Harmonization team of the Analytical Standards (AS) group is looking for an ambitious, process improvement enthusiast with Product
- Release Testing and Change Control Experience help us define the future of analytical change control at the company. In this role, your focus will be
- Improve the compliance for release/stability tests and methods for all our products globally by executing a strategy for harmonizing release tests and specifications from Legacy, Outsourced, and acquired products into the AS system
- Reduce the cycle time for creation of new AS against the historical baseline using LEAN principles
- Play key role in licensure and launch of all new products by creating AS to support manufacture
- Lead integration of critical reagent qualification protocols into the AS system
- To be successful in this role, which works with a diverse slate of customers across organizations globally, both strong technical skills and interpersonal skills are
- critical. Therefore, you should possess the following traits:
- A strong analytical background with small molecule, vaccines, raw materials, or biologics experience
- The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries
- Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with the company’s long term
- Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level
Bachelor’s Degree in a science or engineering discipline or related field
- Thorough understanding of regulatory requirements for testing of drug products and/or medical devices.
- Minimum 7 years’ experience in analytical laboratory testing methods.
- Hands on experience running a variety of analytical methods, which would include two or more of the following: HPLC, densitometry, dissolutions, particle sizing, gel electrophoresis, spectrophotometric assays, immunoassays, cell based assays.
Preferred Experience and Skills:
- Advanced degree
- Experience in qualification of reference standards for small molecules or critical reagents for vaccines and biologics
- Experience with CMC and product filings and the ability to accurately interpret and apply regulatory expectations to the AS
- Experience in analytical techniques for analysis of biological products
- Familiarity with Project Management Programs and philosophies
- Fluency in multiple languages - Experience using Trackwise for analytical change control
- Experience creating final specifications and methods for release of products or raw materials
- Ability to accurately interpret and apply expectations for global compendium
- Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
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