Purpose of the function

Provide leadership and direction based on assigned programs and in close collaboration with the Head of QA R&D, Americas/Europe to ensure that the organization is in a perpetual state of compliance.

Roles and Responsibilities

• Ensuring strategic support is provided to Global Project Team (GPT) assignments and wherever necessary, takes the lead in ensuring procedural documents relevant to GPT as applicable, to relevant GxPs and capture the right level of regulatory importance.
• Partnering and collaborating with key stakeholders (R&D teams) to ensure that key priority programs are adequately supported and that submission-relevant activities are performed.
• Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP).
• Liaising with the Global Audits and Compliance function to ensure compliance with programs assigned and providing lessons learned from audits and inspections to program teams.
• Supporting investigator meetings and CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders.
• Providing guidance to development teams in quality and compliance decision-making to drive sustainable and proactive quality.
• Providing leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. • Led formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course.
• Identifying areas of continuous process improvement and engaging QA teams as necessary as well as key stakeholders. Identifying ways to continuously improve quality and compliance with regulations and company standards, policies, and procedures through a partnership with stakeholders and QA line functions.
• Representing QA in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global RD/PV QA team, ensure inspection management by preparing program teams for FDA, EU, and key HA pre-approval and sponsor monitor inspections; provide inspection management support and follow-up post inspections.
• Providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel specifically for assigned programs or for continuous improvement projects.
• Championing, developing, and driving the implementation of study/program-specific quality plans to ensure proactive management of quality

Further Roles and Responsibilities

• Leadership/ Program oversight
• Quality by Design (QbD) and Continuous Improvement
• Quality by Design (QbD) and Continuous Improvement
• Regulatory Inspections
• Management Review

Education & Experience

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required Master's Degree or other advanced degree preferred
• 7+ years of professional experience in regulated activities, clinical development and QA (preferably) leadership positions, or equivalent experience required
• 7+ years of demonstrated knowledge understanding of global expectations of Health Authorities in the area of Clinical Development
• Must possess a profound understanding of the science of product development
• Demonstrated accomplishments working within a global/matrix environment in the pharmaceutical industry.
• Must have expertise in leading/managing (Global) projects.
• Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.

Skills and additional Requirements

• Ability to work independently and in a team environment.
• Proven track record of successfully leading projects with high impact. preferred
• Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
• Demonstrated organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.
• Strong Industry Network in clinical development. Knowledge and understanding of cultural differences and diversity issues
• Strong written and oral communication skills (English)
• Must have ability to travel up to 30%