Manager, Quality and Compliance

Locations: Remote UK/NL/US

Job Summary

Our Manager, Quality and Compliance works closely with the Associate Director and the Evidence and Access (E&A) Senior Leadership Team in the implementation of quality objectives across the organization. They facilitate high-quality and compliant delivery of HEOR and Market Access projects while working in a fast-paced consultancy environment with a team of like-minded colleagues.

Essential Duties & Responsibilities

• Managing company Standard Operating Procedures (SOPs) and Working Guidelines (WGs):

• • Creating, reviewing, and updating existing documents as necessary
  • Ensuring new and updated SOPs/WGs and associated templates are reviewed, approved, kept up to date, consistent and published in a timely manner
  • Supporting colleagues with the writing of SOPs/WGs and templates as required
  • Managing the tracking of SOP and WG changes, revisions, and version control

• Internally auditing and driving compliance with OPEN Health E&A policies and procedures by:

• • Being an active member of the Quality Group (QG), organizing and running QG meetings and documenting follow-up actions
  • Working with the QG to select topics for internal audit
  • Conducting internal audits according to the agreed audit plan
  • Working with OPEN Health group auditors to facilitate any required internal audits
  • Managing the project issue escalation tracker

• Facilitating and supporting external quality and compliance activities:

• • Working with OPEN Health’s central operations group and other team members to complete due diligence questionnaires from clients and partners
  • Preparing for, coordinating, and facilitating client audits
  • Supporting the Director, Quality and Compliance in developing, implementing, and tracking Corrective and Preventative Actions (CAPAs)

• Qualifying sub-contractors and third-party suppliers (TPS) according to the TPS Qualification SOP:

• • Distributing and reviewing supplier due diligence questionnaires
  • Facilitating external supplier audits where required
  • Managing the OPEN Health E&A third-party supplier list

• Supporting the Governance & Compliance and Learning & Development Teams to manage internal and external compliance training:

• • Facilitating internal training (e.g., policies, SOPs, WGs) and external (e.g., client-specific training, adverse event) sessions for staff
  • Maintaining training records where required

• Collaborating with the Global Governance & Compliance Team on group-level data privacy and compliance initiatives:

• • Cascading and implementing policies
  • Driving the implementation and monitoring of required data protection documentation
  • Supporting the E&A team during data breach reporting
  • Conducting Data Privacy Impact Assessments (DPIAs) and Legitimate Interest Assessments (LIAs) for E&A projects

• Providing advice and support to E&A colleagues to help meet compliance objectives, including support for issue escalation and resolution
• Reporting and reconciling adverse events/serious adverse events per client requirements and timelines
• Supporting internal quality and compliance-related training efforts as needed
• Contributing to high-quality project delivery by ensuring adherence to SOPs, internal policies, and applicable data privacy regulations
• Maintaining accurate documentation and compliance records to support audit readiness and operational transparency
• Staying informed on relevant quality standards, regulatory updates, and industry best practices
• Participating in regular internal team meetings to encourage collaboration and consistent quality approaches
• Assisting Associate Director and CoE leads with problem solving and decision making, particularly where compliance and communication intersect
• Supporting senior project delivery oversight and client satisfaction during escalations or high-impact moments

Experience, Skills, and Qualifications

• Bachelor's degree in life sciences or a related field required; advanced degree preferred
• Minimum of 2 years' experience in a quality or compliance role in healthcare, life sciences, or research
• Proven experience working with data privacy, data collection, and documentation requirements within the research space
• Exposure to RWE and/or PCO studies is strongly preferred
• Background in agency, CRO, pharmaceutical, or consulting environments highly desirable
• Knowledge of regulatory frameworks and research methodologies for non-interventional and HEOR studies
• Experience writing, implementing, and managing SOPs and quality systems
• Strong communication and interpersonal skills; capable of working across functions and with varying levels of seniority
• Demonstrated ability to manage multiple projects and meet critical deadlines with high attention to detail
• Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams); experience using SharePoint preferred

Travel Requirements

• 5-10% potential global travel