- 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.
- 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.
- 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
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Senior Manager, Medical Affairs Quality - North Chicago, United States - AbbVie
Description
Job Description
Job DescriptionCompany DescriptionAbbVie'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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionSenior 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.
Qualifications.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
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