Clinical Project Quality Manager

Job Title: Clinical Project Quality Manager

Location: Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Primary responsibility is to establish and maintain a working relationship with clinical teams to lead quality discussions concerning GCP compliance and contribute to study management decisions from quality perspective.

• Is the GCP ‘expert’ responsible to lead GCP Clinical Inspection Readiness (IR) activities via a project management approach and to contribute to the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs.

• Proposes audit programs to assess areas of study risk and leads the preparation and delivery of Project/Study specific quality reviews. Advises on GCP quality issues and risks, while the study team remains responsible to manage the overall study risks and operational decisions. Supports risk assessments, monitors effectiveness of Risk Mitigation and Risk Prevention approaches, and supports the conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance.

• Is expected to consistently lead in the process for gathering, analyzing, and sharing of best practices and study lessons learned. Identifies when significant changes/improvements to business processes are needed across R&D and beyond and shares with process improvement team. Identifies strategic solutions for continued improvement across clinical, where needed.

About You

Knowledge and Skills:

• Requires knowledge of the drug development process and good knowledge of worldwide GCP compliance regulations, with experience in clinical operations and quality. The following skills are also of particular importance:

• Quality focused with a high degree of personal accountability and commitment

• Strong personal leadership with demonstrated competency to interface with all levels of the organization including senior leaders and influence decisions from a quality perspective Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more clinical trial operations functions / subfunctions

• Good analytical abilities to analyze data and interpret trends to drive action plans to improve business needs.

• Able to analyze new situations and provide guidance on a risk-based approach, even in the absence of established standard or guideline.

• Demonstrated ability as a proactive strategic thinker, conduct impact assessments, root cause analysis, and take the initiative for corrective measures with ability to extrapolate detail without losing sight of big picture.

• Strong project management skills, including:

  • Ability to influence others without direct authority

  • Excellent communication skills (written and verbal), interpersonal skills, diplomacy, and presentation skills,

  • Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.

  • Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines.

• Demonstrated skills in self-motivation, taking initiative and working independently.

Education/Experience:

• Bachelor degree in a life / medical / natural sciences or scientific discipline or equivalent

• Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance

• Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain

• Good working knowledge of standard computer office software

• Competent in English (both written and verbal) to interact effectively in an international environment.

• Minimum of at least 8 years’ experience in the pharmaceutical industry, with at least 5 years’ experience in GCP clinical and/or GCP quality operations-related roles (e.g., GCP auditing, clinical trial monitoring, trial management or Pharmacovigilance) and demonstrated ability to lead complex projects/assignments

Knowledge and Skills Desired:

• Knowledgeable on risk management techniques and methodology

• Knowledge of GCPs and regulations/referential in relation to Quality Risk Management (e.g. ICH E6, Q8, Q9, Q10, EMA reflection paper etc)

• Has successfully managed cross functional Quality projects (Risk Management, Continuous Improvement/QEP).

• Ability to deal with multi-cultural environments

• Experience with FDA, EMA, CFDA or other regulatory inspections of sponsor, investigator sites, or CROs; leadership role is a plus

• Experience with regulatory submissions and e-submissions (NDA, BLA, MAA).

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.​

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