Manager, Quality and Compliance (UK)

April 12

OPEN Health

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Market Access • Brand Communications • Medical Communications • Market Research • Public Relations & Advertising

501 - 1000

Description

• Managing company Standard Operating Procedures (SOPs) and Working Guidelines (WGs) • Internally auditing and driving compliance with OPEN Health E&A policies and procedures • Qualifying sub-contractors and third-party suppliers (TPS) • Supporting the G&C and Learning & Development Teams to manage internal and external compliance training • Collaborating with the Global Governance & Compliance Team on group-level data privacy and compliance-related initiatives • Reporting adverse events/serious adverse events according to client requirements and timelines, including reconciliation as appropriate • Keeping up to date on relevant quality standards, best practices, and regulatory requirements • Assisting with providing internal quality and/or compliance-related training where necessary • Attending regular internal team meetings to facilitate a collaborative approach to all projects • Contributing to the continuing achievements and targets of OPEN Health E&A through the high-quality delivery of projects to agreed standards and timelines • Maintaining quality and accuracy in all activities, following OPEN Health Policies and SOPs and ensuring compliance with data privacy regulations • Supporting the Associate Director and CoE leads with problem solving and management decision making related to improved communication and solid decision management • Overseeing project delivery and acting as a senior decision maker for project escalations with a focus on client satisfaction

Requirements

• A degree in life science or equivalent • Demonstrated experience in a quality or compliance environment • Experience of working within the healthcare or scientific research industry and a good understanding of the different regulatory requirements and research methodologies • In-depth knowledge of quality systems ideally within the pharmaceutical industry • Excellent written and verbal communication skills, fluent in English • Experience of writing clear and unambiguous process documents • Excellent organizational skills with strong attention to detail • Strong leadership skills and the ability to manage people and projects effectively • Meticulous attention to detail, observational and organizational skills • Experience of working in healthcare research in Pharma industry or an agency setting • Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines • Exemplary leadership ability, to effectively articulate quality-related issues to all levels of personnel • Proficient in MS365 including Word, Excel, Power Point, Outlook and Teams • Experience working with SharePoint is preferred

Benefits

• Competitive pay • Comprehensive benefits program • 5-10% potential global travel