- Responsible for leading the Clinical Quality Assurance team to oversee all clinical trials performed or directed by the company.
- Manage the CQA activities including third party, quality plans and internal auditing, risk management and day to day clinical study team support.
- Liaise across Clinical, Medical, Regulatory and R&D departments to proactively identify opportunities to streamline and strengthen clinical Quality process.
- Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.).
- Support the reviews and approves of internal and external audit reports, Quality Events (deviations) and associated Corrective and Preventative Actions within a regulated Quality Management System.
- Represents Clinical Quality expertise across the company with GCLP and GCP including ex-US experience. .
- Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance.
- Leads external Health Authority inspections and internal audits.
- Provides guidance in global regulatory reporting requirements (e.g. serious breach, etc).
- Establishes a global inspection readiness program.
- Bachelor's degree with 15 or more years' experience working in clinical development, preferably in either a clinical compliance or clinical Quality Assurance.
- Must be strategic as well as a hands-on leader who can see "the big picture" while providing guidance to execute daily tasks
- Experience in managing a team of CQA professionals
- Demonstrated Quality Management System experience appropriate for the clinical development including EAP, IST and Collaboration Studies.
- Demonstrated understanding in third party/internal Quality audits, Issue Management and CAPA in a clinical environment.
- Experience leading FDA or other Health Authority Inspections
- Strong knowledge of global clinical trial regulations (e.g. ICH, FDA, etc) and guidelines, particularly in GCLP, and GCP
- Proficient in risk management principles
- Self-motivated with the ability to work effectively in a dynamic environment.
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization to provide solutions to complex situations.
- Excellent critical thinking and problem-solving skills and strong collaborator.
- Ability to effectively manage multiple priorities with a sense of urgency.
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
- Attention to detail and accuracy of work.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- Strong communication skills both written and oral.
- Routine and, or overnight travel required based on business need.
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Sr. Director Clinical Quality Assurance - Bedford, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The Senior Director, Clinical Quality Assurance is responsible for end-to-end Clinical Quality Assurance with an emphasis on radiotherapeutic and diagnostic products. The Senior Director, Clinical Quality Assurance will be responsible for the oversight of all clinical trial performed by the company including international clinical trials, Early Access Programs, Investigational Sponsored Trials and Collaboration studies. This role will oversee all clinical operation activities and third-party qualifications, inspection readiness program, quality plans, policies and quality system elements related to clinical quality activities in support of clinical programs. The Senior Director, Clinical Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment and provide guidance in clinical Quality related areas.
Key Responsibilities/Essential Function
Basic Qualifications
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