CASY-MSCCN Jobs

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose:

The Manager, R&D Quality Assurance & Data Integrity will serve as a liaison between key stakeholders to facilitate the implementation and continuous improvement of the R&D quality system by supporting key activities such as management review, issue escalation, quality agreememnts, and data integrity. They will be responsible for monitoring and reporting on trends, coordinating key project deliverables, and working cross functionally to drive implementation of risk mitigation activities.

Responsibilities:

• Coordinate data integrity reviews and drive implementation of remediation activities.

• Monitor and report on trends identified through routine surveillance of Quality intelligence.

• Lead and/or assist with data integrity remediation activities including any potential validation or procedural updates required to address identified data integrity risks.

• Maintain documentation suite associated with the R&D Data Integrity Strategy.

• Lead and/or coordinate the development of guides, tools and resources to reinforce core quality concepts.

• Support continuous improvement initiatives by driving updates to policies, procedures and training.

• Liaise with key stakeholders to drive timelines and report on key deliverables.

• Provide support for management review by coordinating the collection and reporting of key data from functional area reviews, creating and maintaining review templates, and working with the Quality System team to identify and implement improvements.

• Support and/or lead investigations where there is a known or suspected impact to data integrity. Collaborate cross functionally to identify appropriate CAPA, and monitor/drive implementation.

• Serve as a champion for data integrity by supporting leadership in raising awareness about data integrity, and their role in ensuring compliance. This includes creation and maintenance of training.

• Support and/or conduct impact assessments on regulatory intelligence to identify required updates to the Data Integrity Strategy.

Qualifications

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or other technical/scientific area preferred.

• Minimum 7 years experience in quality assurance.

• Knowledge of applicable regulations, QA systems and GxP compliance requirements including regulations and standards affecting medical device, biologics, pharmaceutical products, and data integrity preferred.

• Works well with guidance to complete tactical objectives.

• Excellent interpersonal skills and negotiation skills.

• Strong computer skills and knowledge of enterprise systems.

• Ability to assess and comprehend complex issues and present solutions in a logical format.

• Demonstrated ability to work across various levels of an organization to drive and influence change.

• Excellent documentation, prioritization, organizational & time management skills.

• Ability to effectively communicate plans, proposals, and actions to management.

• Solution-focused mindset, with demonstrable problem-solving skills. 

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. ​

• This job is eligible to participate in our long-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 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.