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Director of Clinical Compliance, Biopharmaceuticals, Greensboro,
North Carolina
We are seeking a Director of Clinical Compliance for
our biopharmaceutical company client due to growth/expansion.
Our client is dedicated to the development
therapeutics to treat patients with a range of conditions. The company has an experienced management team, a strong pipeline
and multiple products currently in Phase I and Phase II development.
Reporting to the Chief Financial Officer.
Responsibilities
Manage all aspects
of Quality Control, Quality Assurance of clinical research activities
Maintain Standard Operating Procedures that comply
with all applicable regulations and guidelines as required
Ensure that all procedures, policies and systems stay current
per applicable guidelines and regulations
Provide guidance and assessment of regulatory and GCP compliance on all CRU
activities through internal audits, including corrective action planning, debriefing with CRU staff, and ongoing informal
input
Establish and maintain training plans for each group of staff in the CRU
Interact with technical departments,
customers, suppliers and regulatory agencies (i.e. FDA and DEA) in the review of issues and data
Prepare and support
submissions, corrective action plans, and other correspondence with FDA as needed
Actively participate as a member of
the senior management team
Performance management, training and coaching of personnel
Communicate significant
issues or developments identified during quality activities and provide recommended process improvements to the senior management
team
Requirements
Masters or Doctoral level academic qualification in Life Sciences
Minimum
7-10 years of relevant industry experience (Clinical Trial Monitor, Clinical Compliance Specialist, etc.) through positions
of increasing responsibility in clinical research management, with a demonstrated interest in early phase trials
Excellent
oral and written communication and problem solving skills
Excellent project-management skills
Extensive knowledge
of and experience with FDA and DEA regulations and inspections
Knowledge of environmental, safety and health regulations
and inspections (preferred)
Ability to work efficiently with people across all levels and cultures
Excellent coaching
and interpersonal skills
Ability to be a self starter, initiator and team player
Willing to travel occasionally
(10%)
Highly competitive package, commensurate with experience
Please email your cover letter and
resume to ruth@pharmacruiting.com
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About Pharma-Cruiting
- Premier Recruitment of the Elite
Pharma-Cruiting is a dynamic boutique executive recruitment firm specializing
in the recruitment of mid and senior-level executives through C-Suite positions (e.g., CEO, COO, CFO) within the Life Sciences
industries. We provide recruitment expertise in the most sought after areas, including (but not limited to) Pharmaceuticals,
Biotechnology, Medical Devices, Diagnostics, Health, Genetics and Genomics throughout the United States.
With
over 15 years of industry experience, Pharma-Cruiting has achieved the level of expertise and experience necessary to successfully
place elite executive talent giving companies a competitive edge and helping world-class professionals accomplish their dreams.
We distinguish ourselves by "Recruiting only the Elite".
Our accumulation of industry knowledge,
expertise and extensive network of contacts has created sustained working relationships to enable us to create the perfect
match for you.
We deliver exceptional, strategic, comprehensive, and client-focused personalized services.
Our strength is delivering the best and brightest talent aligned with your diversity and inclusion workforce goals.
Professionalism, integrity, excellence in execution and customer satisfaction are our highest priority.
Contact Pharma-Cruiting today for all of your recruitment needs:
215-485-2156 or email at info@pharmacruiting.com
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