Lead, Quality Laboratory Services

Purpose

Serves as the lead for the evaluation implementation and continuous improvement of laboratory technologies workflows and systems supporting New Product Introductions (NPIs) existing product enhancements and lab transformation initiatives. Serves as the key liaison between QC laboratories IT and global functional stakeholders to drive high-impact projects. Provides subject matter expert guidance on test method validation and transfer lab efficiency safety and compliance strategies while mentoring peers and championing innovation across laboratory operations.

Responsibilities

• Leads planning and execution of New Product Introductions (NPIs) within the QC laboratories including evaluation of test methods instrumentation lab readiness and training strategies. Primary point of contact for new testing requests on existing products.
• Serves as the primary QC laboratory representative for cross-functional initiatives representing QC perspectives in global teams and and working with sites in the global network to ensure new test methods and/or technologies are being implemented and executed consistently across the enterprise.
• Works with the Environmental Health and Safety group and appropriate colleagues to develop and implement safety evaluations and proactive risk mitigation control strategies in alignment with regulatory and organizational standards.
• Drives continuous improvement initiatives leveraging data-driven analysis to enhance laboratory workflows efficiency and system/method implementation.
• Serves as the QC subject matter expert and laboratory representative on cross-functional project teams providing strategic direction task delegation and coaching to laboratory team members to ensure timely and successful project delivery.
• Arranges NPI and project support training ensuring knowledge transfer and laboratory readiness for new and updated testing platforms.
• Conducts financial evaluations of lab initiatives including resource planning cost efficiency recommendations and ROI assessments. Oversees material and equipment procurement planning working with the procurement and finance department to ensure alignment with project timelines and budgets.
• Drives method remediation and equivalency studies ensuring scientific integrity and alignment for legacy and evolving methods.
• Manages system configuration and deployment of chromatography and laboratory information management systems to support evolving lab needs including the development and validation of custom calculations.
• Serves as a subject matter expert in method co-validation and transfer providing consultation to global partners and mentoring less-experienced colleagues.

Qualifications :

• Bachelors Degree in Science Engineering or applicable discipline.
• 7 years experience in a regulated or pharmaceutical Quality laboratory environment.
• Skilled in creating and executing validation and transfer protocols method development/remediation and managing controlled documentation.
• Ability to lead complex multi-site or global initiatives involving diverse stakeholder groups.
• Experience in equipment procurement and project financial evaluation.
• Knowledge of laboratory informatics platforms (e.g. Empower SampleManager etc.)
• Strong analytical organizational and communication skills.
• Travel required up to 5% of the time

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time