Job Description
You will serve as a crucial link between global policy and standard setting, and the local implementation within our site business unit(s).
This role is essential in safeguarding the quality and reliability of our organisation's data, which is vital for informed decision making and regulatory compliance.
* Data Operations & Engagement, Culture & Monitoring (ECM) Team Leadership: You will lead and manage the site ECM team successfully.
* Data Governance Implementation: You will deliver and implement site data governance responsibilities and standards.
* Stakeholder Engagement and Management: You will engage and manage stakeholders across the site successfully.
* Global Governance Team Collaboration: You will establish a successful relationship with the global Governance Team to ensure a clear feedback loop.
* DG Training Program Creation and Delivery: You will create and deliver DG training programs in consultation with Global Data Governance Senior Leadership Team.
* Team Resourcing and Support: You will ensure the team has the necessary resources, support, and tools to execute their function effectively.
* Cultural and People Change Management: You will lead cultural and people change management efforts related to DG, ensuring smooth adoption of new processes, systems, and ways of working within the relevant site.
* DG Culture Development and Embedding: You will develop and embed DG culture across all elements of IOPS site work, working closely with ECM Specialists.
* Global Standards and Policies Delivery: You will work with DG Business Partners to deliver global standards, policies, and procedures at site level and monitor adherence to these standards.
* Quality and DG Culture Promotion: You will foster a culture of quality and DG within the organisation and promote its importance across all departments.
* Communication and Collaboration: You will drive communication and collaboration between stakeholders to ensure effective DG practices.
* Embedding DG Principles: You will lead/support initiatives to embed DG principles into the company's core values and everyday practices.
Requirements
* Technical Knowledge: You must have technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills.
* DG Policy Implementation Experience: You should have experience implementing DG policies and initiatives within business units in a regulated environment.
* Cultural/People Change Management Experience: You should have experience in cultural/people change management and driving cultural change related to DG.
* Knowledge of Regulations: You should be familiar with applicable federal, state, and local regulations, rules, policies, and procedures such as GDPR, FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
* Data Governance Principles Understanding: You should have a strong understanding of data governance principles, regulatory requirements, and industry standards, and the practical application of these in business operations.
* Partnering and Influencing Experience: You should have extensive experience demonstrating ability to partner, influence, and incorporate new standards.
* Leadership and Team Experience: You should have strong people management and team leadership experience.
* Training Program Management Experience: You should have experience managing and implementing training programs and monitoring KPI achievement.
* Stakeholder Management and Influencing Skills: You should possess strong stakeholder management and influencing skills.
* Adaptability: You should be able to adapt in the face of changing business needs.
Qualifications
* Education: You must hold a BA/BS degree.
* Experience: You should have 12+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.