AbbVie

BTS Compliance Manager - Allergan Aesthetics

Posted on: 1 Apr 2021

Irvine, CA

Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Provides leadership and direction to global Commercial Allergan Aesthetics Business Technology Solutions (AA BTS) team members on compliance policy, process, and procedures. Develops and drives improvement programs related to AA BTS Compliance policy, processes and procedures. Leads and drives global AA BTS Compliance activities across multiple projects and client areas. Leads efforts to ensure Allergan Aesthetics Commercial website, application and system development activities are documented in compliance with global policy and procedures. Supports strategy to develop the implementation of testing methodologies and/or BTS Global Compliance practices across multiple divisions. Works closely with AbbVie Director Global Commercial BTS Risk Management and BTS Global Commercial Compliance team in monitoring, tracking, enhancing, and reporting overall BTS Commercial compliance with both AbbVie and external regulatory requirements.

Key Responsibilities Include:

* Responsible for the interpretation and communication of systems compliance regulations within all AA BTS Commercial functions.
* Develops and proposes solutions to ensure on-going compliance with industry rules and regulations (internal & external) which are critical to organization success and impact achievement of business area objectives. Contributes to business process improvement and overall knowledge of the organization.
* Provides guidance to affiliate AA BTS staff in understanding the SLC requirements (System Characterization, Change Characterization, Quick Hits, Personal Data Assessment, Data Classification etc.), the preparation and execution of compliance activities for new or revised applications/systems at the functional business unit level.
* Responsible for oversight and coordination of global AA Commercial BTS audit planning activities. Key liaison with Affiliate and audit team members during each audit. Monitors and tracks audit recommendations to closure. Partners with BTS Global Commercial Compliance team to prepare for and during internal audits.
* Supports Director BTS Global Commercial Risk Management in developing, implementing and monitoring processes and measures to drive AA BTS Commercial global (US and OUS) compliance with applicable Corporate and Divisional Policies and procedures.
* Consolidates AA BTS Commercial Compliance KPIs and metrics and prepares monthly leadership reports. Strategizes and develops new Compliance KPIs and improvement solutions for activities noted for improvement opportunity.
* Establishes and maintains productive relationships with all levels in BTS, business functions and with external partners. Acts as a liaison and BTS Compliance SME to assure successful implementations. Serves as a source of information on the BTS Compliance needs and regulatory environment.

Qualifications
Required:

* Bachelor's Degree
* Atleast 8 years of experience in a quality systems environment and compliance, or equivalent combined work experience; experience in compliance strategy, planning and implementation
* 8+ years of project management experience; ability to prioritize and multi-task work activities
* Demonstrative experience in and understanding of Information Technology (IT) environment
* Excellent analytical, judgment, consultative capabilities, and communication skills; ability to work with BTS management and staff
* Executive presence and ability to communicate to all levels of the organization
* Strong communication and writing skills
* Ability to drive outstanding performance and gain commitment through developing, coaching, motivating, energizing and inspiring team members.
* Excellent Microsoft Excel and PowerPoint skills; ability to develop executive level presentations with minimal oversight
* Strategic thinker with the ability to detect, assess and develop solutions as needed for complex BTS topics
* Knowledge of pharmaceutical/medical device industry

Preferred:

* International work experience

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

AbbVie

Chicago, IL

AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.

It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.

Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.