Quality Assurance Manager (GMP, CLIA) - Cancer Diagnostics (Microbial)

Our client, an RTP-based company that is developing cutting-edge technology in cancer diagnostics, is actively recruiting for an exceedingly competent and knowledgeable Quality professional to join its team.

The company has developed technology that, from patient-derived samples, will help oncologists pinpoint the optimal cancer treatment for each patient.  This is a transformative platform that will have significant impact on the lives and healing of cancer patients.  The company is supported in its mission by top healthcare venture firms. 

It is an exciting time and an exciting company.  Having the right people in place to drive Quality and Compliance is essential.  This Quality Manager will play a key role.

Things to Note:

• This position will report to the Head of Quality and Compliance and, in collaboration with him, will develop and implement all Quality procedures and processes.  It is a hands-on management role.
• The focus will be to work with departments, project teams, and management to ensure compliance of deliverables and products. This will include developing, maintaining, and executing Quality procedures.  Seek a “thinker and a doer” with a strong background in developing and deploying Quality initiatives.
• The company works with human samples.  Seek candidates who understand aseptic technique and the Quality procedures needed to ensure a sterile work area, sterile reagents and media, sterile handling, etc. Strong preference for candidates with background in microbials.  CLIA experience is also preferred.
• This is a highly interactive role.  This QAM will regularly interface with colleagues (and suppliers) regarding Quality matters.  Further, this QAM will be the primary trainer of personnel on Quality techniques, standards and expectations.  Right candidate will bring excellent communication skills.
• This is an emerging company in which policies, practices and procedures are still being developed and/or enhanced.  Seek candidate who thrives in a “start-up” setting and who brings tremendous initiative, ingenuity, drive and absolute commitment to patient.

Selected Duties:

• Ensures that the organization operates within established policies/procedures and complies with applicable governmental regulations (GMP, CLIA, EMA, etc.)
• Develops, maintains, and provides expertise on site quality and/or business systems, tools, data, procedures, etc.
• Works directly with company teams to provide process oversight and to support them in ensuring compliance
• Manages, tracks, and reports status of Quality Systems programs including Deviation Management, Corrective Action and Preventive Action (CAPA), Change Control, and Quality Risk Management
• Supports validation activities by creating, contributing, reviewing, and / or approving associated deliverables
• Schedules, plans, conducts, and documents internal and supplier audits
• Supports regulatory and customer audit/inspection readiness of the organization; reviews audit outcomes to ensure appropriate and timely corrective actions are implemented
• Creates and maintains risk assessments to ensure program / project risks are identified, assessed, mitigated, and closed
• Conducts Quality-focused training sessions to educate employees on quality programs, SOPs and best practices
• Performs quality reviews of technical documents to assure the accuracy, completeness, and clarity.

Targeted candidate will offer a related degree and 5+ years of Quality Assuranceexperience in the life science industries.  Deep expertise in GMP standards and practices expected and required. CLIA lab experience strongly preferred.

In addition, we seek candidates who bring experience working in an emerging setting in which they were responsible for developing, implementing and training others in Quality programs and initiatives.

Other priorities include:

• Microbials, including aseptic technique
• Audit readiness and oversight experience
• Experience leading deviation investigations through to root cause and CAPA development
• Experience training others and overseeing their application of Quality programs; strong communication
• Excellent organizational and project management skills
• Independent, self-directed work style; demonstrated ability to “own” the area
• Flexibility, adaptability and resourcefulness; ability to work well in a highly dynamic setting

Finally, we seek a quick study who will work exceedingly well with others and will champion the Quality mission within the company.

This company is doing important work, and we seek a candidate who is eager to contribute to its success.

Local candidates only.  Please forward resume for prompt consideration.