Quality Manager, Quality Assurance

ERGOMED; Pune District; Vor Ort; INR 1.800.000 - 3.000.000; Vollzeit

Zusammenfassung

Ergomed is a specialist CRO focused on rare disease and select oncology trials, delivering high-quality QA leadership across internal and vendor audits. The Quality Manager will drive the audit universe, risk assessments, and compliance with GCP, GVP, and applicable regulations, partnering with procurement and operations to ensure timely, compliant findings closure.

We seek a professional with 3+ years of GCP/GVP auditing and 2+ years in audit program management, fluent in English, and capable

Qualifikationen

• Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or related field
• Experience with GVP and GCP regulatory requirements
• At least 3 years auditing experience in GCP and/or GVP
• At least 2 years of audit program management experience
• Fluent in English

Aufgaben

• Develops and maintains the internal Quality Risk Assessment methodology and Audit Universe.
• Leads QA activities related to procurement and vendor oversight.
• Manages audits per the Company Audit Plan and oversees pre- and post-audit activities.
• Provides GxP QA consultancy for Quality as a Service initiatives.
• Monitors compliance to identify and address audit strategy and plan impacts

Kenntnisse

Organization

Attention to detail

Communication

Facilitation

English fluency

Ausbildung

Bachelor's/Master's in biomedical sciences or related

Jobbeschreibung

Company Description

Medicine moves forward here. So will you.

Medicine moves forward here. So will you.

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

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 consultancy 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

• 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

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.