Director of Quality Assurance and Regulatory Affairs
Our primary mission is to provide the highest quality orthopaedic implants to restore, repair and regenerate the biological and mechanical functionality that has been lost as a result of degenerative disease and/or trauma related incidents.
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.
- 30 Days
- 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
- 60 Days:
- 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
- 90 Days:
- Begin equipment validation dossiers
- Begin internal/external material vendor audits
- Integration of ERP system with QMS and design control documentation for product development