Quality Manager – Quality Assurance

This is a fully remote position, open to applicants in India.

📋 Description

• Promote a culture of quality within the organization and serve as an ambassador for the QA department.

• Prepare, uphold, and execute internal and vendor Strategic and Annual Audit Programs.

• Spearhead the design, execution, and administration of internal and vendor audits.

• Oversee related quality risk management initiatives.

• Formulate and sustain the internal Quality Risk Assessment methodology.

• Create and maintain a comprehensive Audit Universe.

• Direct Quality Assurance efforts pertaining to procurement and vendor oversight.

• Develop, manage, and uphold mechanisms for continuous monitoring and adherence to relevant laws and regulations, including EU GVP, USFDA CFRs, JMPA, and ICH-E6.

• Collaborate with Vendor Management and operations teams to implement a risk-based and compliant audit strategy.

• Coordinate and participate in internal system and vendor audits as outlined in the Company Audit Plan.

• Manage pre-audit and post-audit processes.

• Execute audits or coordinate peer reviews of audit documentation and quality control activities within the GxP expertise area.

• Plan, coordinate, or conduct audits and provide GxP QA consultancy for client-contracted Quality as a Service activities.

• Monitor organizational compliance and evaluate impacts on audit strategy, plans, and execution.

⛳️ Requirements

• 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 pertinent industry experience.

• Familiarity with both GVP and GCP regulatory requirements, or a willingness to expand expertise.

• Minimum of 3 years of direct auditing experience in GCP and/or GVP domains.

• At least 2 years of experience in managing audit programs, including the development and upkeep of risk-based audit plans.

• Strong organizational skills and meticulous attention to detail.

• Exceptional communication and facilitation skills within a global organization.

• A proactive mindset.

• Proficiency in English.

🏝️ Benefits

• Option for remote work.

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible work setting.

• Focus on work-life balance.

• Chance to influence clinical research, pharmacovigilance, and quality consulting.