Senior Quality Manager, Client Quality Management

ERGOMED; Pune District; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Ergomed Group is seeking a Senior Quality Manager to implement and maintain our quality system across client projects in the pharma space. You will lead quality activities, drive improvements and ensure compliance with global regulations, client requirements, and GxP standards.

You will develop project-specific Quality Management Plans, handle audits and CAPAs, monitor KPIs, and mentor junior staff while coordinating with QA and Audit teams to uphold the highest standards of patient safety and

Qualifications

• Life Sciences degree with pharmacovigilance experience in a GxP environment.
• Strong organizational skills and attention to detail.
• Excellent communication skills across stakeholders.
• Leadership qualities; line management is desirable.
• Proficient IT skills and data handling capabilities.

Responsibilities

• Oversee all project-related quality activities across assigned client projects.
• Drive quality improvements and provide expert quality advice.
• Manage client quality-related activities for projects.
• Develop and maintain a project-specific Quality Management Plan.
• Serve as main contact for audit-related activities and CAPA management.
• Ensure relevant quality KPIs are defined and monitored.
• Provide quality content and analysis for monthly project reports.
• Collaborate with Quality Management, QA and Audit teams to ensure QMS adherence.
• Support junior team members and participate in training on client projects.

Skills

Pharmacovigilance

QA leadership

Communication

IT skills

GxP compliance

Education

Life Sciences degree

Job description

Company Description

Medicine moves forward here. So will you.

Company Description

Medicine moves forward here. So will you.
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And that is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.

Job Description

The Senior Quality Manager is primarily responsible for the implementation and maintenance of the quality system and training for their assigned client projects, ensuring that the project maintains compliance with global regulations, legislation, PrimeVigilance and Client requirements. They drive quality
Core responsibilities

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project.
• Develop and maintain a project specific Quality Management Plan.
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project.
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

Qualifications

• Life Sciences degree
• Strong previous pharmacovigilance experience including quality and compliance experience within a GxP environment
• Good organisational skills, attention to detail and excellent communications skills
• Must have leadership qualities (Line Management experience is desirable)
• Good IT skills

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.