Associate Director - US Contact Center Quality, Compliance & Training

Employer
AbbVie
Location
Lake County, IL, US
Posted
Nov 17, 2018
Ref
1807635
Required Education
Bachelors Degree
Position Type
Full time
Purpose: Establish and oversee an effective quality management system for the CC call types/stakeholder requirements - Product quality, Medical Information, Adverse Event and Commercial. At a minimum this system must ensure compliance with US regulatory requirements and AbbVie standards. The scope extends to collaboration with VMT and spans all marketed products.
In addition this individual will help shape our culture, our organization to help make a remarkable impact on Abbvie customers.

Key Responsibilities Includes:

  • Establish AbbVie quality management processes for the contact center call review that meet applicable PPS, RDQA, and stakeholder standards and ensure reproducible, controlled, and timely delivery of high quality outputs in collaboration with BPO.
  • Establish Contact center training plan for all business lines and product lines.
  • Collaborating with management to ensure that staff forward looking strategy to ensure staff are trained to meet the needs of the business demand forecasted.
  • Collaborate with vendor management team and internal partners to implement internal quality and vendor quality management processes which integrate with supplier and AbbVie processes wherever possible, setting clear accountabilities, responsibilities and expectations across all involved parties. Utilize risk-proportionate monitoring paradigms for in-line and retrospective evaluations.
  • Maintain a forward-looking quality plan and lead proactive solution development for impactful changes, such as new AbbVie or regulatory requirements, additional service, technology updates, or other identified opportunities or deficiencies. Collaborates with Vendor Management team to understand impacts across vendor.
  • Designs, manages and approves training matrices for contact center staff and supplier staff ensuring each role is properly trained for all job functions.
  • Develops materials and delivers training sessions (through multiple modalities) in conjunction with VMT and or the supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
  • Tracks delivery of training to internal staff, including certification of new hires/progression in-role. Provides consultation and guidance on supplier training model and materials in conjunction with VMT. Ensures training records are current and audits training records for Contact Center staff.
  • Establishes the call quality review program with leadership. Monitors Contact Center employee performance via call quality reviews and facilitates integration of feedback to management for performance management and feedback.
  • Contact Center representative for audits and inspections. Facilitates internal/third-party audits and health authority inspections of supplier services or AbbVie oversight.
  • Ensure appropriate issue management systems (eg CAPA tracking) are in-place, leveraging and coordinating between established AbbVie and Safety Compliance/ PVQA .
  • Responsible for communicating and collaborating across stakeholders for proactive identification and prioritization of issues, as well as timely, effective, and permanent remediation efforts.
  • Evaluates new regulations and guidelines, develops plans and processes for implementation
  • Communicates and coordinates across functional and global boundaries to ensure timely training of AE, PQ, MI to ensure compliance of work
  • Identifies, evaluates, develops and implements Global Products Safety policies, processes and system improvements.
  • Manages the audit process, prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters)
  • Works cross-divisionally to influence business processes which impact product safety.


  • Bachelor's degree with related health sciences background, licensed healthcare professional required. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.
  • Candidates lacking the appropriate degree but with equivalent previous management or leadership experience may be considered.
  • 4-10 years' clinical health care and previous pharmaceutical industry experience
  • Preferred - Pharmaceutical industry contact center experience.
  • Strong knowledge of US contact center requirements including PQ, AE and MI requirements, including regulations and commercial environment, with a firm understanding of related quality assurance systems (including audits/inspections) and adult professional training model
  • Preferred experience in inspections and internal/third-party audits
    Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans, audit/health authority responses or submissions
    Influence across multiple stakeholders and manage across a matrix environment; seen as a collaborative partner at all levels of the organization
  • Proactively identify, rapidly assess, and effectively manage business and compliance risks
  • Strong knowledge of relevant outsourcing processes, project management

STAKEHOLDERS

  • Provides guidance and shares expertise with internal and external customers, such as Product Quality, Medical Information, Commercial, ODC, R&D QA.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled