Quality Assurance ConsultantDescription: Acts as a Subject Matter Expert on applicable standards and regulations for the organization. Drives inspection readiness and improvement to regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites. Provides corporate training on inspection readiness, inspection process and best practices. Conducts internal audits to ensure a constant state of compliance. Plans and executes compliance audits of internal operations to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards. Manages the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc., identifying impact driving resolution to close gaps. Responds in a timely manner to compliance concerns and contribute to problem resolution. Trends audit / inspection findings and observations. Communicates results expediently to leadership and applicable groups. Supports and may lead quality and process improvements aimed at addressing compliance gaps and continuous improvement; supporting a LEAN company culture.Skills:
Quality assurance
Audit
Compliance
quality management review
ICH
Gmp
Capa
Fda
regulatory
Additional Skills & Qualifications: Bachelor’s degree in a related medical, science or business discipline and minimum 7+ years’ functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries; or equivalent combination of education and experience. Minimum 5+ years in auditing role. Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
