Associate Director/Director, Quality and Compliance (US)

Associate Director/Director, Quality and Compliance

Reports to Director of Operations

Job Summary

Our Associate Director, Quality and Compliance provides leadership and guidance to colleagues, ensuring high standards and timely and sustainable completion of projects. This is done by overseeing the development and updating of the Quality Management System and ongoing compliance associated with it ensuring that all legal and ethical requirements are met.

This individual also supports improvements related to internal processes and governance around new business development, client onboarding, and life cycle management of projects.

Associate Director, Quality and Compliance will work in a fast-paced consultancy environment with a team of like-minded colleagues specifically within OPEN Health’s Evidence & Access (E&A) Center of Excellence (CoE).

Level of experience and ability to effectively manage members of the team along with partnering with the Practice and Operations Leads to create efficiencies justifies a more senior role.

Essential Duties & Responsibilities

• Overseeing the development, implementation, and monitoring of quality processes within the E&A business unit and specialist teams
• Complying and ensuring practice-wide compliance, with all required laws, regulations, applicable guidelines, and ethical standards
• Overseeing preparations, conduct and responses to client quality audits within the E&A practice
• Providing guidance on best practices for efficiency, sustainability and innovation, which will maintain and raise standards of quality
• Maintaining up to date knowledge of internal and industry SOPs according to industry standards & requirements
• Overseeing project delivery and acting as a senior decision maker for project escalations with a focus on client satisfaction
• Participating in Senior Leadership Team meetings with the aim of providing input on targeted, quality, and strategy efforts
• Supporting the project delivery teams with problem solving and management decision making related to improved communication and solid decision management
• Supporting the OPEN Health Central team in completing both client-required vendor qualification assessments and due diligence assessments of potential subcontractor companies.
• Overseeing the conduct of Quality group meetings including setting agendas and identifying key priorities on a monthly, quarterly, and annual basis.
• Fulfilling the role of Data Privacy Champion for the E&A practice
• Supporting the project delivery teams to best understand the current healthcare environment and the commercial objectives of our clients
• Supporting project delivery teams in the multi-disciplinary review of scoping findings conducted by colleagues; ensure scientific solutions are appropriately recommended to clients
• Providing consultancy to clients on ethics, law and Good Practice relating to E&A projects
• Collaborating with other designated team members to provide final OPEN Health review and approval (as needed) of project deliverables (e.g. protocols, ethics documentation, reports, manuscripts, abstracts, posters)
• Facilitating the timely identification, dissemination, and implementation of key learnings via attendance at regular Project Review meetings
• Offering mentor support and leading appropriate colleague training related to project development and delivery arising from issues identified
• Leading the resolution of issues arising during and after a project, in particular where compliance with regulations is involved
• Committing to personal development and maintaining training log
• When needed, liaising with client as a representative of OPEN Health, to ensure successful project delivery
• Supporting new business growth by identifying potential project opportunities

Experience, Skills, and Qualifications

• 10+ years of relevant experience in Quality and Compliance role
• Detailed knowledge of laws, regulations, and guidance applicable to E&A projects, i.e., non-interventional research.
• Experience building and/or maintaining a Quality Management System (QMS)
• Experience of working in healthcare research in Pharma industry or an agency setting
• Knowledge of structure and function of the NHS and UK healthcare environment
• Experience conducting healthcare data collection projects or reviewing study methodologies
• Clinical knowledge and experience across a range of therapeutic areas
• Strong leadership skills and the ability to manage people and projects effectively
• Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines
• Meticulous attention to detail, observational and organizational skills
• Proficient in MS365 including Word, Excel, Power Point, Outlook and Teams
• Strong written/verbal communication skills

Travel Requirements

5-10% potential travel globally

About OPEN Health

OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing. Working in partnership with our clients, we embrace our different perspectives and strengths to deliver fresh thinking and solutions that make a difference.

OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns.

What we offer:

As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program

• Competitive pay, generous paid vacation and holidays, and health insurance programs across all our locations
• Ongoing training and development opportunities which foster and shape your individual career path
• An active and growing commitment to bettering the communities our employees call home through our Corporate Social Responsibility program
• The opportunity to thrive in a global, collaborative environment while working every day to improve health outcomes and patient wellbeing
• Diverse, inclusive culture that encourages you to bring your whole self to work

If we sound like the sort of business environment in which you would thrive, then we would love to hear from you.