The PharmaDx Quality System Project Manager works within the New Technology group to coordinate and facilitate all quality and compliance aspects of the group’s pharmaceutical projects. On the front end, the Quality System Project Manager is essential to the planning and hosting of onsite visits, including quality assessments, audits and inspections. During the life of each pharmaceutical collaboration, the Quality System Project Manager will work to develop, organize and manage important internal documents, such as SOPs, org charts, time accounting logs and invoices. The Quality System Project Manager will work closely with each team to implement Design Control principles and will manage associated processes and documents. The Quality System Project Manager Coordinator will contribute to the management of FDA submission documents and correspondences. Post-market, the Quality System Project Manager will participate in important reporting and documentation processes.
This position works under the direction of the Director of the PharmaDx group .
Establishment of New Pharma Projects
1. Fields inquiries to ARUP by pharmaceutical companies regarding laboratory testing services.
2. Creates and maintains a log of all pharmaceutical requests.
3. Assigns New Technology Group leaders to evaluate requests.
4. Makes arrangements for pharma site visits/assessments/audits, including setting up appointments and obtaining necessary agreements such as Nondisclosure Agreements (confidentiality) and Business Associate Agreements (privacy).
5. Leads visitors on facility tours, together with ARUP Marketing/Sales Support staff.
6. Manages visitor review of important documents, procedures and reports via MasterControl, together with Technical Supervisors and Compliance/Quality Systems staff.
7. Coordinates ARUP’s response to quality assessment reports resulting from site visits.
New Test Development/Validation
1. Together with the PharmaDx Director, drafts test-specific FDA compliant Design Control documents according to plans developed by New Technology Group Project Manager.
2. Manages test Design History files.
3. Collects and organizes all documents generated during test planning, development and validation; documents important milestones .
4. Documents important milestones during test development/validation.
5. Prepares reports/summaries on behalf of pharma partners at specified intervals.
6. Manages time/effort reporting to pharmas; drafts and tracks invoices; records payments.
FDA Submission and Post-Market Commitments
1. Collects appropriate FDA submission forms.
2. Organizes test submission documents into master file, including Design Control documents.
3. Works with internal and external contractors to submit tests to FDA as needed.
4. Following FDA approval or completion of other pharma project, collects documents for annual reporting.
5. Collects documents pertaining to test re-validation or test changes.
- Coordinates efforts with Compliance and Quality Systems pertaining to pharma projects, FDA submissions and other interactions.
- Performs other duties as assigned.
- Bachelor’s degree in one of the biological sciences
- Minimum two years of experience in research or clinical laboratory setting
- Minimum two years of managing complex project(s)
- Excellent proficiency in Microsoft Word, Excel and Powerpoint.
Physical and other requirements
- Experience in quality control and quality assurance
- Experience with MasterControl document control software
- Experience drafting and editing SOPs
- Experience drafting quality audit reports
- Experience in Good Laboratory Practice environment
- Experience in pharmaceutical development
- Demonstrated ability to manage and track complex issues and projects to completion
- Demonstrated experience with computerized systems, database management, and spreadsheet and word processing programs to manipulate data and create reports
- Ability to organize work, meet deadlines, and work under stressful conditions
- Must be able to work well with end users, vendors, consultants, and all levels of ARUP management
- Ability to set priorities and be flexible as demands and priorities change
- Ability to keep records and to maintain records in a neat and orderly fashion
- Self starter with strong attention to detail
- Regular and reliable attendance
- Excellent customer service skills
- Ability to work well as a team member and foster positive relationships with coworkers
- Ability to communicate fluently in English, both orally and written
- Successful completion of a credit check.
ARUP Laboratories - 17 months ago
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