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

• Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.

• Take a lead in the Clinical audit program by planning and executing all types of clinical audits and working with auditees to resolve any non-compliance identified. Regularly leads more complex/challenging audits.

• Lead/contribute to risk-based assessments to identify potential audits.

• Advance the AbbVie Quality System through leading and/or contributing to the development and implementation of systems and processes required to support global quality assurance requirements.

• Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.

• May act as Audit Lead/SME for an assigned audit type. Responsible for maintaining standards including tools/templates and guidance documents and participates in onboarding new auditors for that audit type.

• Mentor, coach and train Clinical Audit staff.

• Participate in and supports GCP inspections, as required.

• Recognised as a SME; provides support and consultation to RDQA and business partners with regards to Clinical Quality and GCP regulations.

Qualifications

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience

• 3-5 years of experience in the biopharmaceutical industry (Quality Assurance and/or Clinical Research Development) or with a regulatory authority

• 3-5 years of experience in Clinical Quality Assurance or equivalent area

• Strong analytical skills and the ability to draw conclusions from presented data

• Ability to work effectively and efficiently, promote a dynamic environment with minimal supervision

• High level of awareness and understanding of clinical trial regulations (e.g., ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices

• Flexibility to adapt to changing assignments and ability to effectively prioritize

• Good project management, interpersonal, and communication skills with ability to work independently and as part of a team

• Willingness and ability to perform international travel

Additional Information

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html