General Summary

Advarra provides institutional review board (IRB) review, institutional bio-safety review (IBC), GxP and Human Research Protection Program consulting as well as integrated technology solutions (CTMS, Clinical Trial Management Systems) to facilitate the conduct of research. Advarra's client base is broad and includes pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. The Senior Director, Quality Assurance reports to the Senior Vice President Quality Assurance, Process Improvement & Training and is responsible for supporting initiatives that ensure Advarra compliance with regulatory requirements and best practices.

The Sr Director of Quality Assurance leads planning and execution of quality management systems and practices at Advarra. This includes but is not limited to the implementation of Quality policies, practices, procedures, standards, and systems necessary to ensure the compliance of operations to relevant regulations. This individual will be a key leader and a champion for quality principles and compliance within the entire organization.

Principal Duties & Responsibilities

Provide leadership and build an exceptional team to manage Quality Assurance across IRB and clinical trial products and services
Lead and host compliance audits and regulatory inspections by competent regulatory authority and external clients
Oversee accreditation and certification requirements that pertain to company products or services
Lead internal audits of relevant systems
Oversee CAPA (Corrective and Preventive Action) program and resolution of audit findings
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance
Collaborate with other leaders across the organization and assist in the continuous improvement and management of GMP policies and quality management system (QMS)
Develop internal SOPs guiding auditing, change management, and training; managed within an electronic document management system/QMS
Be a problem-solver and teach problem-solving, using critical thinking and quality tools to find practical solutions that address root causes.
Promote adoption of new practices as we learn, grow, and regulations and client expectations evolve.
Oversee Supply Chain quality activities; both suppliers to us and where we are a supplier to another organization.
Oversee quality management of computer systems and Part 11 (Data Integrity) requirements.
Share working knowledge of Quality Tools & Process Improvement
Develop relationships with counterparts in client organizations as appropriate for the company's priorities and objectives
Other duties as assigned

Requirements:

Education

BS in relevant science (including life sciences, medical technology, engineering or equivalent) is required, MS is preferred. Bachelor's degree and related experience including supervisory experience, or a combination of relevant education and experience will be considered
The ideal candidate will have 10+ years of industry experience in managing Quality functions

Experience

Demonstrated Quality leadership through a partnership approach with operations and other business functions to enable high quality and compliant services distribution
Demonstrated experience building and leading exceptional Quality Assurance and compliance teams
Experience in continuous improvement and operational excellence
Experience in a lead role and interactions with federal agencies, i.e. FDA, accreditation, and client audits
10+ years of relevant and current work experience in healthcare industry Quality Assurance required
10+ years of demonstrated management experience with evidence of being an impactful, influential, and involved leader and mentor
Experience with ISO 27001 Information Security Management System or other ISO standards helpful

Knowledge/Skills/Abilities

Expert knowledge of Quality Assurance and compliance in Good Clinical Practice (GCP); as related to IRB (Institutional Review Board) services
Knowledge of pertinent FDA & HHS regulations and ICH (International Conference on Harmonization) standards
Demonstrates comprehensive knowledge of regulatory and compliance concerns relative to research involving human subjects
Demonstrated experience building and leading exceptional teams
Demonstrated success in setting and communicating goals and expectations, measuring accomplishments, delegating responsibility, keeping others informed, coaching, reinforcing positive behavior and managing conflict.
Excellent communication and organizational skills and superb attention to detail
Critical thinking skills; demonstrated problem solving skills
Demonstrated ability to collaborate with multi-disciplinary project teams
Experience in continuous improvement and operational excellence
Demonstrated consistency and dependability in performance (quantity & quality) of work
Ability to effectively manage remote workforce
Experience with electronic quality management systems and document control as well as MS Office products and database applications required

Physical and Mental Requirements:

Sit or stand for extended periods of time at stationary workstation
Regularly carry, raise, and lower objects of up to 10 Lbs.
Learn and comprehend basic instructions
Focus and attention to tasks and responsibilities
Verbal communication; listening and understanding, responding and speaking

EEO Statement Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets

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