Senior Manager, Medical Affairs Quality ( On-Site, IL Based)

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

Senior Manager Medical Affairs Quality Assurance is responsible for providing independent quality oversight of GxP activities executed by AbbVie's Medical Affairs enterprise, including but not limited to non-interventional studies, medical information and other regulatory commitments., covering the AbbVie drug, device and cosmetic portfolio.

The role reports to a Director of Safety, Vigilance and Medical Affairs Quality Assurance. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.

• Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures through review of compliance and quality system data.

• Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards while positioning AbbVie for future success.

• Contribute to a holistic quality assurance model for Medical Affairs, inclusive of internal and vendor performed activities. Partner with Medical Affairs and Epidemiology execute a proportionate quality assurance oversight model for non-interventional studies and regulatory commitments.

• Promotes continuous education with regards to applicable regulations and expectations for self and other AbbVie staff.

• Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance and support business process owners directly to ensure quality is integrated at all stages of process development.

• Actively participate and lead front and back-room GxP inspection activities, with direct involvement that includes expert guidance to enable successful inspections with safety, RA and MA topics in scope.

• Is recognized as a resource for consultation regarding worldwide MA and non-interventional research regulations and corporate policies, especially for CAPA and associated quality disciplines.

Qualifications

Qualifications.

• Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.

• Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.

• Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.

• The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational/administrative skills and sound judgment.

• Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and across divisional and technical areas.

• 6+ years in Quality Assurance with some management experience preferred and three more years in another function in the pharmaceutical, medical device/nutritional or related industry. Four years in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 10 years.

• ASQ certification desired.

Additional Information

Applicable only to applicants