GCP Quality Manager/Specialist (Low Travel) – Raleigh Pharma (Work from Home Option)
Our client, a Raleigh area biopharmaceutical Company in high growth mode, is actively recruiting for an exceedingly sharp and knowledgeable candidate to join its Clinical Quality team. While Raleigh-Durham area candidates are preferred, client is open to remote candidates, presuming they are prepared to travel to Raleigh regularly.
This is a clinical stage Company with several products in the later stages of development – both oral dosage and biologics. The Company is preparing for both NDA and BLA submissions and near-term focus for this role will be inspection readiness. We seek a Clinical Quality specialist who can drive the effort to ensure compliance and preparedness.
Key Things to Note:
- This Manager is responsible for leading QA oversight of Good Clinical Practices (GCP) and assuring compliance of projects with worldwide regulations and guidelines. There are ~ 15 active studies at this time.
- Site audits are performed by an outside vendor. This Manager will focus on cGCP compliance of home office clinical teams. Strong bkgd in Clinical Ops will be important.
- In addition to developing strategies that will ensure compliance, this GCP QA Manager will help train clinical personnel in GCP practices and prepare them for inspections. Seek candidate whose technical knowledge is complemented by superb communication and interpersonal skills.
- This is an emerging Company in which policies and procedures are still being developed and enhanced, and where priorities shift regularly. Seek hands-on, flexible, resourceful and innovative manager who will thrive in this dynamic and building setting.
- Travel is estimated at 10-25% (depending on location to Raleigh)
- In partnership with internal Clinical Op, Medical Monitors, Drug Safety, and Pharmacovigilance, carry out Quality plans for oversight of internal and external clinical activities
- Facilitate the suite of inspection readiness activities with all stakeholders; maintain the inspection readiness dashboard
- Facilitate the analysis of existing systems and processes for PAI risk and mitigation analysis
- Prepare for and support regulatory inspections of Company and vendors
- Support the development of Quality metrics and report Quality activity updates to Clinical Quality management
- Act as a technical resource on GCP matters to field and internal contacts
- Proactively identify and escalate Quality issues and discrepancies. Resolve issues in collaboration with the GCP QA leadership and external partners
- Ensure Clinical Development compliance with all applicable regulations and standards
- Engage in the development and improvement of systems and processes; participate in the development of configuration, testing, or validation activities for GXP Clinical systems such as EDC, IXRS, or eTMF
- Contribute to the development, implementation, and maintenance of GCP Quality SOPs
- Provide Clinical Quality review of clinical study documents
Targeted candidate will offer a related degree and 5+ years of directly related experience in Clinical Operations including substantial experience in Quality GCP activities. Inspection readiness experience highly preferred.
Other priorities include:
- Knowledge of relevant FDA/ICH regulations/guidelines with particular expertise in GCP standards and practices
- Familiarity with NDA and BLA requirements; experience contributing to Clinical sections a major plus
- Experience working in emerging pharma and helping them develop Quality practices that evolve as the company evolves
- Ability to influence without authority
- Excellent writing skills – including SOPs
- Record of impact and longevity
Finally, we seek a hands-on, make-things-happen manager; one who will work exceedingly well in a dynamic and empowered setting. This is an exciting company at a very exciting time. Seek a top-notch candidate who will thrive.
Please forward Word resume for prompt consideration.