Director, Risk & Program Management Quality Operations

Updated: September 7, 2021
Location: Morrisville, NC, United States
Job ID: 135440


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Overview

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Responsibilities

You’ll join The Risk And Program Management Group within Syneos Health Consulting. You will assist pharma consortiums in facilitating the myriad legal, financial, and operational risks and nuances of program management. 

More specifically: 

A Director within the Risk and Program Management Advisory Group is an experienced thought leader in the biopharmaceutical industry and a trusted advisor to clients with accountability for maintaining the REMS Integrated Solution Quality Program.  As a visible leader in the Consulting business, the Director drives commercial success by helping secure profitable business, creating leads, and explaining to clients how our REMS quality strategy fuels their success.  In addition, the Director will leverage subject matter expertise and business relationships to identify industry trends and incorporate them into client work, thought leadership, and new service offerings.

REMS Operations Office  
  • Key member of the cross-functional REMS Operations Office (ROO)
  • Drives broad organizational understanding regarding ROO and REMS Integrated Solution (RIS) capabilities
  • Establishes RIS quality metrics and provides periodic updates to leadership and during ROO meetings

 REMS Quality Program  

  • Leads the development, implementation, and maintenance of the REMS Integrated Solution (RIS) Quality Program
  • Designs and implements the RIS process audit program, updates leadership regarding outcomes, and recommends options to drive continuous improvement
  • Maintains the RIS controlled document (CD) review schedule, provides SME support to RIS business teams as they introduce or update CDs, and conducts a formal review of all RIS CD’s
  • Establishes and maintains the RIS quality ontology model (which codes internal and external stakeholder deviations, non-compliance, issues, failures, near miss etc.), and drives integration across all relevant RIS activities
  • Works with RIS business leaders to explain the critical nature of the RIS quality program to their teams, and helps drive a quality culture
  • Coaches and trains RIS business teams in quality-related matters
  • Monitors execution of RIS business teams quality control strategies
  • Maintains the RIS disaster recovery test strategy, provides guidance to internal teams regarding their business continuity and disaster recovery plans

 Failure Investigations

  • Implements a failure investigation process across the RIS business teams
  • Advises RIS business teams regarding their root cause analysis and proposed corrective and preventative actions
  • Analyzes failure investigation data, and recommends options to drive continuous improvement

 SME Support

  • Coaches and trains RIS business teams in quality-related matters
  • Maintains expert knowledge in global risk management and PV quality topics (legislation, regulations, guidance, industry info, etc.), and updates leadership with relevant details
  • Advises RIS business teams regarding the design and implementation of effective quality control strategies
  • Demonstrates specialized subject matter expertise regarding RIS activities
  • Cultivates strong external relationships with risk management quality experts and relevant industry groups

 Inspections and Audits

  • Implements strategies for RIS business teams to maintain a state of inspection/audit preparedness (e.g. periodic evaluations of training records, mock inspections, inspection readiness training etc.)
  • Supports the Head of Commercial Quality Assurance (CQA) with any RIS focused inspections or client audits
  • Supports the Head of CQA address any RIS inspection/audit findings, and drives implementation of appropriate effectiveness check measures

 Business Development

  • Provides support for RIS quality-related responses to RFPs and bid defenses
  • Seeks opportunities to drive additional business by expanding RIS service offerings through new quality focused activities
  • Reviews RIS vendor contracts and technical quality agreements regarding RIS quality interests

 Other

  • Represents the RIS business team on the development of relevant company policies, procedures, and process improvement initiatives
  • Maintains highly effective working relationships with internal stakeholders (e.g. Corporate Quality, Compliance and Ethics, Data Privacy, etc.)
  • Other duties as assigned

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • Bachelor’s degree in a science/health care field, or equivalent with significant experience (7+ years)
  • Comprehensive experience interpreting and applying REMS regulatory requirements
  • Strong knowledge regarding post-marketing pharmacovigilance regulatory requirements, and GvP quality systems
  • Previous experience working on a REMS program is preferred
  • Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency)
  • Possesses cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
  • Significant experience operating in a cross-functional environment
  • Ability to act independently and proactively
  • Strong organizational, presentation and interpersonal skills
  • Excellent team building skills

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.

WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

 


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