Title:  Associate Manager - Quality Assurance

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

ou will be responsible for: 
1.    Quality Management:
•    Develop, review, and update PV policies, procedures, and SOPs to ensure they are current and compliant.
•    Monitor and report on PV compliance metrics and trends.
•    Support the implementation and maintenance of PV quality management systems.
•    Manage, direct and control a quality assurance process, responsible for the evaluation and consistent handling of adverse events, ensuring compliance with reporting timelines and quality standards.
•    Communicate the observations to the applicable stakeholders and ensure the appropriate root cause analysis (RCA)/corrective action and preventive action (CAPA).
•    Present Quality data to the responsible internal stakeholders in an appropriate forum as required.
•    Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines.

2.    Training and Support:
•    Provide training on PV regulations, compliance requirements, and company SOPs to relevant staff.
•    Act as a subject matter expert for PV compliance queries and issues.
•    Discuss and set up development plans with/for all team members to further develop   individual’s skills and potentials.
•    Set up the training plans for new hires according to the individual’s experience and job role and ensure that training is provided to team as appropriate.
•    Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines.

3.    Risk Management:
•    Identify, assess, and mitigate risks related to PV activities.
•    Develop and maintain risk management plans and ensure timely implementation of risk mitigation strategies.

4.    Documentation and Reporting:
•    Ensure accurate and timely documentation of compliance activities.
•    Prepare compliance reports for senior management and regulatory authorities as required.
•    Maintain inspection readiness documentation.
•    Review, author and update standard operating procedures (SOP) and support in global initiatives for ensuring enhanced quality and compliance.
5.    Regulatory Compliance and Late Case Analysis
•    Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
•    Keep up-to-date with changes in PV regulations and standards and implement necessary adjustments within the organization.
•    Conduct in-depth investigations into the root causes of delays in case processing and submission.
6.    Cross-functional Collaboration:
•    Work closely with other departments, such as Clinical, Regulatory Affairs, and Quality Assurance, to ensure coordinated and compliant PV activities.
•    Participate in cross-functional teams to support PV compliance initiatives.

Skills:
•    Excel skills
•    Good communication skills
•    Good interpersonal skills
•    Possess attention to detail
Your impact: 
About you: (Desired profile)
Must have: • Attention to detail • Critical thinking and analytical skills • Good comprehension skills. • Good communication (verbal and written), with fluency in English and interpersonal skills. 
Nice to have: (Additional desired qualities) Team management and people management experience and certificate in QMS.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.