Quality Manager, Quality Assurance

PrimeVigilance Ltd.; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

PrimeVigilance Ltd. in Pune, India, seeks a Quality Manager to foster a culture of quality across QA and vendor oversight. You will design and manage audit programs, lead GxP audits, and ensure regulatory compliance.

The role requires strong organization, communication, and leadership, with experience in GCP/GVP audits and risk-based planning. You will collaborate with procurement, operations, and vendors to uphold quality standards and continuous improvement.

Qualifications

• Bachelor's or Master’s degree in biomedical/natural/health sciences or related field.
• Experience with GXP regulatory requirements or willingness to broaden expertise.
• 3+ years direct auditing experience in GCP and/or GVP; risk-based audit planning.

Responsibilities

• Leads design, implementation and management of internal and vendor audits.
• Coordinates audits per the Company Audit Plan, including pre- and post-audit activities.
• Ensures compliance with laws and regulations such as EU GVP, USFDA CFRs, JMPA, ICH-E6.
• Provides GxP QA consultancy for client contracted services within QA.
• Monitors audit strategy impact and updates plans accordingly.

Skills

Organization skills

Attention to detail

Communication

Facilitation

Fluent English

Education

Bachelor/Master in biomedical/natural/health sciences

Job description

The Quality Manager position is key in fostering a culture of quality within the Company organization and acts as an ambassador for the QA department. The Quality Manager, Quality Assurance has an active role in the preparation, maintenance, and execution of the internal and vendor Strategic and Annual Audit Program as well as leading all aspects of the design, implementation and management of internal and vendor audits and corresonding quality risk management activities. Core responsibilities of the Quality Manager are

• Audit Universe
  • Develops and maintains the internal Quality Risk Assessment methodology.
  • Develops and maintains a comprehensive Audit Universe.
  • Leads Quality Assurance activities in relation to procurement and vendor oversight.
  • Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
  • Partners closely with Vendor Management and operations teams, driving risk-based and compliant audit strategy.
• Auditing and Audit management
  • Coordinates and contributes to internal system and/or vendor audits initiated by the Company, according to the Company Audit Plan, including effective management of pre-audit and post-audit activities.
  • As required, and within their area of GxP expertise, conducts audits or coordinates audit documentation peer review and quality control activities.
• Other
  • For Client contracted services within Quality Assurance area, undertakes activities in relation to the Quality as a Service, such as planning, coordinating or conducting audits, and providing GxP QA consultantcy in line with their expertise and experience.
  • Monitors compliance within the organization to ensure early identification and review its impact on audit strategy, audit plans and its execution. Qualifications

Qualifications

• Education: Bachelor s or Master s degree in biomedical sciences, natural sciences, health sciences, or another relevant scientific discipline, or an equivalent combination of advanced education and relevant industry experience
• Experience:
  • Experience with both GVP and GCP regulatory requirements, or a willingness to broaden your expertise
  • At least 3 years of direct auditing experience in GCP (e. g. investigational sites, TMFs, Vendors) and / or GVP area (e. g. safety case processing and reporting)
  • At least 2 years of experience in audit program management including the development and maintenance of risk-based audit plans
• Skills: Organization skills, attention to details, excellent communication and facilitation skills within a global organization, proactive, fluent in English