Manager, Quality and Compliance (US)

Manager, Quality and Compliance

Reports to Associate Director/Director, Quality and Compliance

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 the 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 as required
• Preparing for, coordinating, and facilitating client audits
• Supporting the Associate Director, Quality and Compliance by developing, implementing, and tracking Corrective and Preventative Actions (CAPAs) after audits
• 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 G&C and Learning & Development Teams to manage internal and external compliance training:
• Facilitating internal training (policies, SOPs, and WGs) and external (e.g., client-specific training, adverse event) for staff members and maintaining training records when required
• Collaborating with the Global Governance & Compliance Team on group-level data privacy and compliance-related initiatives:
• Cascading and implementing policies
• Driving the implementation and monitoring of the required documentation of data protection processes
• Supporting the OPEN Health E&A team in the event of any data breach reporting
• Conducting data privacy impact assessments (DPIAs) and Legitimate Interest Assessments (LIAs) for OPEN Health E&A projects
• Providing advice and support to colleagues in E&A business areas to help them meet quality and/or compliance-related objectives and responsibilities
• Reporting adverse events/serious adverse events according to client requirements and timelines, including reconciliation as appropriate
• Supporting other quality and/or compliance-related administration duties as required
• 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 thorough working records of all activities
• 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

Experience, Skills, and Qualifications

• A degree in life science or equivalent with a minimum of 2 years’ 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 in SharePoint is preferred

Travel Requirements

5-10% potential global travel

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.