Job Overview
At our organization, we are seeking a highly skilled professional to fill the position of R&D and Pharmacovigilance Compliance Lead.
This role is focused on ensuring compliance with evolving laws and regulations to protect patients and uphold our reputation.
The successful candidate will be responsible for supporting stakeholders in investigating significant events, emphasizing quality by design, right-first-time practices, and inspection readiness during all development phases of compounds globally.
Key Responsibilities
The R&D and PV Compliance Lead will collaborate with diverse stakeholders, including internal teams and external partners. This individual will:
* Plan and execute quality activities independently to ensure subject safety and data integrity, complying with regulations, procedures, and contractual agreements.
* Partner or lead compliance investigations and ensure timely closure of corrective and preventive actions from assigned deviations, audits, and/or change control processes impacting regulatory processes.
* Escalate issues early and ensure effective risk-based resolution are in place.
* Leverage internal stakeholders and subject matter experts network to develop appropriate action plans, decisions, and ensure efficient actions are taken to ensure compliance.
Requirements
The ideal candidate will possess:
* A Bachelor's Degree required; Master's Degree preferred in Life Sciences Related Field.
* Preferable 10 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 5 years in the research, clinical development, or Pharmacovigilance domain.
* Proficient in research/GLP, GCP, and/or GVP regulations and applicable regulatory framework.
* Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles.
* Expertise in managing non-compliance, root-cause investigations, and robust CAPA development in at least one of the GxPs.
* Experience in leading transversal quality/process optimization projects, background in continuous improvement methodologies.
* Ability to analyze data, perform trend analysis, and lead meaningful discussions with business management for meeting compliance requirements.
* Experience working with data analysis tools and notion of applying AI and Machine Learning in the pharmaceutical industry.
* Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results.
* Skilled in influencing others within a global matrix organization and driving informed decision-making.
* Manages quality and compliance issues with diligence, rigor, transparency, and timeliness.
* Proficient in presenting complex projects and issues clearly and succinctly.
* Excellent planning, organizational, presentation, training, communication, and interpersonal skills.
What We Offer
Our organization is committed to providing a dynamic and supportive work environment that fosters growth and innovation.
We offer a competitive compensation package, comprehensive benefits, and opportunities for professional development.
Join us in making a difference in the lives of patients worldwide.