Senior Director, Quality Assurance - (R1033760) in Cambridge, MA at IQVIA™

Date Posted: 7/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Cambridge, MA
  • Experience:
    Greater than 15 years
  • Date Posted:
    7/30/2018
  • Job ID:
    R1033760

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE:


Oversee the Quality Assurance program for assigned region. Direct the standard operating procedure management system and ensure coordination of worldwide operating procedures.

(Regional responsibility)


RESPONSIBILITIES:
  • Working with the customer Quality counterpart, project teams, and functional management to proactively promote, support and facilitate compliance, the identification and management of risks and quality improvement 
  •  Ensure quality assurance organization and operating procedures are in place to support audit program.
  • Supporting the management and resolution of significant issues relating to quality; facilitate root cause analyses and the identification and implementation of robust and pragmatic corrective and preventive actions.Support Inspection Readiness activities.
  • Providing actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement. 
  • Developing internal Project/Account related audit plans and scopes to evaluate risk controls and identify emerging risks.
  • Participate in or lead teams for special projects as assigned. Teams may be cross functional.
  • Ensure industry standards training of department staff for regulatory inspections.
  •  Supervise consultation, guidance, tracking, and metrics system.
  •  Interface with senior management to discuss quality and compliance issues
  • Interface with business development and operations to identify business opportunities
  • Recommend staff management actions in accordance with organization’s policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
  • Perform quality assurance consulting projects, audits, and results analysis within budget and established timelines.
  •  Host customer audits and prepare corrective action plans.
  • Driving inspection readiness activities for the customer, including contributing to mock inspections by/of the customer  
  • Advising on the strategy for and collaborating in the preparation for and management of Regulatory Authority (RA) inspections at customer offices and, as necessary, at investigator sites.
  •  Preparing for and actively participating in Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts. 

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
  •  Knowledge of word-processing, spreadsheet, and database applications.
  •  Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
  •  Considerable knowledge of quality assurance processes and procedures.
  •  Strong interpersonal skills.
  •  Excellent problem solving, risk analysis and negotiation skills.
  •  Effective organization, communication, and team orientation skills.
  •  Ability to influence and guide others.
  •  Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
  • Bachelor’s/primary degree
  •  15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience; or equivalent combination of education, training and experience ; or equivalent combination of education, training and experience.


PHYSICAL REQUIREMENTS:
  •  Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
  • Travel is required and may include some international travel. 


EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1033760