Director/Associate Director | Compliance
2 weeks ago
Associate Director/Director, Quality and Compliance (UK)
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.
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
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
Extensive experience in Quality and Compliance role
Detailed knowledge of laws, regulations, and guidance applicable to E&A projects, i.e., Experience building and/or maintaining a Quality Management System (QMS)
Experience conducting healthcare data collection projects or reviewing study methodologies
Strong leadership skills and the ability to manage people and projects effectively
Proficient in MS365 including Word, Excel, Power Point, Outlook and Teams
Travel Requirements
5-10% potential travel globally
OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing. OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns.
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
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