Senior Director R&D Quality Assurance

 erik.lombere@lombereindustries.com

TITLE: Senior Director R&D Quality Assurance 
DEPARTMENT: R&D Quality Assurance 
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties & responsibilities. The order in which the duties & responsibilities are listed is not significant.
Position Summary: 6 month contract, near full time hours, potentially renewable. 
Responsible for managing the R&D Quality Assurance activities including all R&D related audits and associated quality system processes within the GCP, GLP and GVP Quality Management System (QMS). The GCP, GLP and GVP audit responsibilities include internal and external (contract service providers) functions and processes conducted within Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and applicable Computer System Validation regulations as required by all relevant regulatory agencies.  
Primary Responsibilities:
Audit activities include all aspects of planning, execution, reporting, and procedural documentation associated with internal and external audits and resource planning necessary to conduct all audits. Scope includes external contract service providers (CSPs), clinical trial sites, and internal development teams and processes.  

GCP, GLP and GVP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, application of System Development Life Cycle, and quality metrics. Quality systems activities will be coordinated with the GMP Quality Systems group.

Support for Regulatory Inspections including, but not limited to, FDA, EMA, and other regulatory bodies as required. Will provide senior management with updates and status of responses to regulatory inspections.

Will act as a representative to the clinical operations team and other development teams to ensure compliance with GCP, GVP, GLP and System Development Life Cycle requirements.

Management and leadership for the audit and quality systems team including resource planning, budgeting and forecast support.
Education/Experience/Skills:
Master’s degree in neuroscience, psychology, biochemistry, clinical pharmacology or related, PhD preferred. An equivalent combination of relevant education and applicable job experience may be considered.  
Minimum 15 years’ of progressively responsible pharmaceutical experience in R&D quality systems, FDA and EMEA regulations with direct experience with GCP, Pharmacovigilance and System Development Life Cycle activities. 
Minimum of 10 years’ experience in a leadership role with direct management of a team of GCP/GVP/SDLC quality professionals
• Experience with clinical development and subsequent commercialization of at least one product (small molecule preferred).
• Experience with Pharmacovigilance.
• Experience directly hosting GCP and post marketing (GVP) inspections.
• Experience with clinical site and pharmacovigilance audit management, and SDLC activities.
• Experience with R&D vendor management and clinical site audits.
• Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality.
• Experience with multi-sized organizations from start-up to large employers desired.
• Familiarity with Central Nervous System (CNS) therapeutic area a big plus.

Must possess:
• Knowledge of R&D quality systems.
• Knowledge of GCP, GLP, Pharmacovigilance, and SDLC applicable domestic and international regulations.
• Knowledge of GLP, GCP, Pharmacovigilance, and SDLC applicable domestic and international compliance audit concepts.  
• Excellent communication skills, both verbal and written. Able to work independently as well as in a cross-functional, multi-cultural team.  
• Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues.  
• Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions. Frequent internal and external contacts with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals. 
• Ability to travel 25% of the time.
Scope:
Establishes strategic plans for designated function(s). Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.

Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.