Sr Manager, Quality Assurance

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.  

Provide overall leadership for the functions and responsibilities to establish comprehensive quality processes and systems. Manage the quality assurance oversight of projects, assignments, training, and staff for Veranex Data Management & Analytics service line.

Provide insights, analyses, and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification, and mitigation quality, process, productivity/efficiency improvement initiatives.

Oversee & coordinate assigned QA activities in support of customers, functionals, audit and inspection programs, or QA quality management system for Veranex Data Management & Analytics service line.

Minimum Requirements

• Bachelor's Degree in Life Sciences/Pharma
• 12 to 15 years’ experience Quality Assurance experience in CRO environment with a strong knowledge of pharmaceutical and CRO processes and regulatory environments
• GCP Quality Assurance auditing experience
• Experience in working for ISO QMS and ISMS audits is a must.
• Good verbal and written skills. Good communication, interpersonal skills, and attention to details. Organized and proactive approach to work.
• Ability to work independently and in a group.

Roles & Responsibility

• Provide guidance, interpretation, support, training, and key inputs in implementation and compliance to regulations, guidelines, corporate standards, and policies.
• Take of the role of Management Representative for the service line and support with certification process.
• Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to projects.
• Plan, conduct, report, and follow-up of internal audits, in accordance with current SOP(s) and participate in the review of corrective action plans, as assigned.
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory inspections, as assigned.
• Support Inspection Readiness Activities
• Promote the concept of quality, the principles of quality management and implement quality improvements.
• Review relevant project documentation for compliance with GCP and corporate procedures.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.