Clinical Quality Manager

Job Description

ProPharma Group Clinical Research Services (“CRS”) focuses on providing program management and execution-based consulting within the life science industry. The Clinical Quality Manager serves in an important role within the CRS Quality and Regulatory Compliance function to assist in ensuring multiple QMS areas are in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations. The CQM eports to the Director (Head) of Clinical Quality Assurance, or designee.

Essential Responsbiltiies Include:

Administration of the Training and Document Control module within CRS’s eQMS, ZenQMS, which includes user accounts and training courses.

• Oversee the document management process, which includes formatting, distributing, tracking, working with functional area heads, and managing the process both in ZenQMS and in network folders and SharePoint sites
• Communication with newly hired personnel of the training requirements for their role.
• Management of any personnel training records outside of ZenQMS.
• Run and manage training reports for functional departments and studies, track training compliance.
• Perform tracking of quality system deliverables such as CAPAs/Deviations, audit responses, and vendor management activities.
• Maintain updated QMS reports such as the controlled document index, approved vendor lists, and validated systems list.
• Coordinate audit schedules with clients and Treximo SMEs; participate in client audits, as needed.
• Prepare Management Meeting agendas, take meeting notes and distribute them.
• Contribute to the development of Quality procedures and processes.
• Support CRS’s quality management programs of internal audits, supplier management, and metrics reporting.
• Performs other quality and compliance related activities, as delegated by the Head of Quality Assurance.

Qualifications

Qualified candidates must have:

• B.S./B.A. preferably in life sciences or healthcare, or equivalent experience.

• Must have 5+ years of relevant experience, preferably in the health care, pharmaceutical, or medical device industries.

• Experience with digital signature tools, electronic document repositories, and Microsoft programs (MS Word, Excel, PowerPoint).

• Understanding of Quality Management System standards and best practices such as 21 CFR Part 11 (GCP, GLP, GMP), ICH, ISO, Six Sigma, Kaizen, ANSI.

• Experience with digital signature tools, electronic document repositories, eQMS systems, and Microsoft programs (MS Word, Excel, PowerPoint).

• Track record of sound judgment including abstract thinking and a good balance between an academic and pragmatic approach.

• Excellent communication skills with being able to formulate vision and translate vision into execution with measurable results.
• Strong people skills, ability to work with stakeholders inside and outside of the company, able to mentor team members, build and lead teams with diverse backgrounds.
• Champion for organizational change to build quality and compliance culture.
• Effective interpersonal communication skills.
• Excellent organization skills and attention to detail.
• Strong written communication skills.
• Proven ability to prioritize workload, manage complex projects, and meet deadlines.
• Flexible and proactive toward changing needs.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.