Director of Quality Assurance and Regulatory Affairs
August 31, 2018
Las Vegas, Nevada
Full Time - Experienced
As the second full time employee, this individual will have significant influence in the creation, design, implementation and ongoing management of all aspects of the quality, compliance and regulatory foundation of the company. This position, requires a high level of competency in building, implementing and trouble-shooting basic systems, policies and procedures that comply with state, federal, international and voluntary societal regulations. The candidate is expected to be an expert authority in their technical field, challenge conventional thinking in a cooperative way, navigate start-up challenges by being able to function in a variety of different technical and social environments with minimal supervision, driven by continuous improvement and product quality metrics and possess methodical critical thinking skills.
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Ability to implement and manage all aspects of the quality system to support Good Manufacturing Practices (GMP) manufacturing and distribution of Class II medical devices and allograft derived products
Ensure systems, policies, and procedures are compliant with all relevant regulations and standards set forth by regulatory, quality and/or accrediting agencies (required FDA and ISO). Experience with American Association of Tissue Banks (AATB) and international agencies Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) is preferred.
Represents the organization on government policy and compliance matters that relate to facility inspections, registrations and product filings (national and international)
Establish corporate quality key performance indicators for management review sessions
Responsible for product safety, complaint investigations and reporting as a result of process changes, planned waivers, deviations and/or recalls of GMP manufacturing, packaging, clinical labeling errors and/or adverse events
Provide regulatory guidance for the development of test methodologies, validations, vendors, supply chain, new facility construction, new manufacturing process, etc.
Establish and direct the implementation of departmental and staff objectives, goals, policies and budgets. Monitor, report and review performance against these goals plans and budgets on a routine basis
Ability to promote the organization, its vision and reinforce brand awareness and visibility
Represent the organization at events, functions, society and conference meetings
Ability to recruit and retain top talent
Ability to motivate team members through strong leadership and effective communication
Ability to provide agile, creative solutions to expedite go-to-market strategies
Interact with internal and external customers to ensure the best possible QA/RA customer experience
POSITION VALUE CREATION:
Support and provide input on strategic direction for department, company and customers
Have deep network of contacts to facilitate the completion of strategic initiatives
Ability to grow with company from start-up through full scale operations
Support the review and execution of clinical trials and creation of more complex product applications (IND, BLA)
Dynamic, fast paced start-up environment
Relentless focus on execution, accountability, quality and delivery schedule
Apply agile and creative solutions to build disruptive business model
Experience: Minimum of 12 years managing direct and indirect staff/consultants within a fast paced, highly regulated GMP manufacturing environment (e.g. Medical Device, Biologics and/or Pharmaceutical industries). Candidates with tissue banking experience a definite plus.
Education: B.A/B.Sc. in physical, applied and/or life sciences, engineering or mathematics is required.
Candidates with advanced degrees (M.S., MBA, PhD, JD, MD) and/or experience in microbiology, materials science, clinical affairs, statistics and/or orthopedics will receive priority.
Certificates from accredited programs, American Society for Quality (ASQ) Certified Quality Auditor (CQA), Regulatory Affairs Certificate (RAC), Certified Tissue Bank Specialist (CTBS) are strongly recommended.
Create and present Quality and Regulatory budget, resource, staffing and timing strategy
Perform GAP analysis on existing documentation
Assemble QMS requirements, vendor and pricing options
Select cloud based QMS
Populate QMS with prioritized key procedures/policies
Work with Director of Operations on selection of enterprise resource planning (ERP) software package
Begin equipment validation dossiers
Begin internal/external material vendor audits
Integration of ERP system with QMS and design control documentation for product development