Job Information
OPEN Health Manager, Quality and Compliance (US) in New Jersey
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.