Director, Qa & Compliance Jobs

Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.
General Summary:
The Director, Quality Assurance is responsible for leadership of Quality Assurance leaders at Advarra to ensure compliance of the company’s services and products with recognized regulations, client requirements, best practices, and guidelines. The Director QA reports to the SVP QA and will help establish the quality systems, including plans and policies. This individual will help design, implement, and maintain QA and compliance programs, including procedures, CAPA, and support external and internal audits. This is a client-facing role and will interact with various leaders across the company. Leadership, critical thinking, adaptability, leading change, and developing self and others are important for success in this role.
Advarra provides Institutional Review Board (IRB) review, Institutional Biosafety Committee (IBC), Data Monitoring Committee / Endpoint Adjudication Committee, Consulting, and technology solutions in support of clinical trial management. Advarra’s client base is broad and includes pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. The Director, Quality Assurance reports to the Senior Vice President Quality Assurance and is responsible for supporting initiatives to ensure Advarra compliance with regulatory requirements and best practices.
Principal Duties & Responsibilities:

• Oversee accreditation and certification requirements that pertain to company products or services.
• Foster collaborative working relationships with internal and external constituencies
• Lead and host compliance audits and regulatory inspections by regulatory authorities and external clients.
• Other duties as assigned
• Direct development and implementation of quality systems and procedures to ensure compliance with regulations, best practices, and guidelines to ensure reliability and consistency with respect to products and services across the company.
• Oversee CAPA (Corrective and Preventive Action) program and resolution of audit findings.
• Lead, manage, and develop a team of QA professionals across IRB (Institutional Review Board) and clinical trial products and services.
• Lead internal audits of relevant systems.

Requirements:
Education

• Bachelor’s Degree in relevant science or engineering (including life sciences, medical technology, engineering or equivalent)

Experience

• Leadership experience with evidence of developing people and leading improvement activities.
• Experience with leading major Quality Assurance systems (like SOP/documentation management, CAPA, and audits)
• Demonstrated leadership experience within healthcare industry Quality Assurance (preference to experience with clinical trials). Ideally, 10+ years of industry experience.
• Experience interacting with federal agencies (like FDA), accreditation agencies (like AAHRPP and ISO), and clients (through audits and CAPA).

Knowledge/Skills/Abilities

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

Physical and Mental Requirements:

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

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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