50 Northern Ave
| Fully Remote
Category: Life Sciences, Project/Program Management
Job Number: 17723
Position: Senior Manager, GCP Quality - Regulatory Surveillance & Inspection Readiness
Job Type: Contract
Duration: 6 months
This position will manage the global GCP Regulatory Surveillance process that is used to monitor new and updated regulations impacting the clinical space. This will include triaging existing global regulatory information, working with functional process owners to evaluate for potential impact on our client's processes, documenting the outcome of the triage in tracking systems, and making process improvements to the existing Regulatory Surveillance process. This position will also be involved with inspection readiness activities as required.
Key Duties & Responsibilities
- Triaging regulatory surveillance information housed in a tracking system and document outcome within the tracking system.
- When needed, collaborate with subject matter experts/process owners to determine if there is any impact.
- In collaboration with other quality teams, make process improvements to the existing regulatory surveillance process
- Perform inspection readiness activities such as prestaging documents, help others write storyboards, performing document review, and other readiness activities as needed
Required Education Level
- Bachelor’s degree in life sciences, computer science, economics or other discipline requiring quantitative skills preferred
- 6 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in quality and continuous improvement
- Experience with collaborating with cross functional teams and motivating them to achieve common goals
- Preference for experience in managing regulatory surveillance/intelligence activities
- Preference for experience in Good Clinical Practices (GCP) activities
- Hands-on experience leading projects
- Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
- Strong interpersonal communication skills
- Passion for continuous improvement and demonstrated problem solving skills
- High attentiveness to detail
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.
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