Senior Scientist I, Analytical Operations Outsourcing and Compliance

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Responsibilities

• Manage outsourcing activities as the single point of contact for the internal project teams, QA, business operations, procurement and the external service provider.
• Coordinate, plan and monitor outsourced analytical work to external and internal service providers.
• Accompany outsourced analytical work packages from initial request over quote, contract, testing order, analyses related coordination to invoice verification to meet given timelines and budget.
• Support monitoring of service providers and the identification and qualification of new external partners.
• Author, verify and archive documents in a GMP environment
• Work with different areas towards a standardized, compliant, and effective global outsourcing process.
• Support with the management of investigations occurring at external and internal service providers
• Act as a change owner following the applicable CM process
• Provide the necessary QCC support for outsourced analytical work
• Develop/align local processes/workflows and GMP approaches within PDS&T LC and global processes in close cooperation with other PDS&T sites and partner organizations.

Qualifications

• Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Possess thorough theoretical and practical understanding of own scientific discipline.
• Minimum 3 years of experience in the pharmaceutical industry with exposure to analytical and/or formulation development and expertise in GMP areas.
• Knowledge of GMP requirements and regulations.
• Is self-motivated, self-reliant, hard-working, and able to work in a fast-paced global environment
• Learns fast, grasps the essence and can change course quickly when indicated to manage and meet priorities and timelines
• Pays attention to quality and detail
• Brings good communication and collaboration skills
• Demonstrated problem solving skills
• Is competent with software programs, including MS Excel, PowerPoint, Word, Power BI
• Has proven flexibility to deal with changing timelines and shifting work priorities.

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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic 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 aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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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