Champion Quality Excellence for Biostatistics & Statistical Programming
We are a global leader in pharmaceutical development seeking an experienced Senior Quality & Risk Management Lead to serve as the dedicated quality partner for our India-based Biostatistics and Statistical Programming teams. In this strategic remote role, you will be the central point for all quality-related activities, providing expert consultancy, driving quality culture, and ensuring compliance across a critical portfolio of data science functions.
This position is essential for maintaining the integrity of our clinical data and statistical outputs. You will not just oversee compliance—you will mentor teams, lead complex investigations, and embed proactive quality practices into the fabric of our operations in India.
Your Key Responsibilities
Primary Quality Partnership for India Teams:
- Act as the primary Quality representative and consultant for the India-based Biostatistics and Statistical Programming teams, partnering directly with the functional heads.
- Provide expert quality and risk management support for all activities within these functions, from protocol development through to regulatory submission.
- Lead and manage Quality Event support, including overseeing investigations, performing root cause analysis (RCA), and ensuring robust Corrective and Preventive Action (CAPA) development and tracking.
Audit Support & Compliance Leadership:
- Serve as the key quality lead during internal and external audits and inspections for the supported functions.
- Prepare teams for audits, manage audit responses, and ensure timely closure of findings.
- Apply mastery of ICH-GCP principles and relevant regulatory guidelines (e.g., FDA, EMA) to provide strategic compliance guidance.
Process Improvement & Mentorship:
- Support the development, review, and implementation of functional Standard Operating Procedures (SOPs) and process improvements.
- Lead and participate in global quality initiatives to enhance quality systems and drive efficiency.
- Mentor and develop team members in quality principles, risk management, and compliance best practices.
- Provide leadership and oversight for complex, multi-project accounts within the quality framework.
Your Profile: Qualifications & Experience
Education:
- Bachelor’s degree in Life Sciences, Statistics, Computer Science, or a related health/science discipline.
- An advanced degree (Master's) in a science, technology, or industry-related field is strongly preferred.
Experience & Expertise:
- 8-12 years of experience in clinical research, with significant exposure to Biostatistics, Statistical Programming, or Data Management functions.
- Demonstrated experience in Quality Assurance, Quality Control, or Risk Management within a pharmaceutical, biotech, or CRO setting.
- Proven expertise in root cause analysis methodologies and effective CAPA management.
- Comprehensive, practical knowledge of ICH-GCP guidelines and global regulatory requirements.
Skills & Attributes:
- Proven ability to lead, mentor, and influence in a matrix environment without direct line authority.
- Excellent problem-solving and analytical skills, with the ability to manage complex quality scenarios.
- Outstanding communication skills in English (both written and oral); additional languages are an asset.
- A proactive, collaborative leader who can build strong partnerships with functional heads and team members.
Ready to be the strategic quality anchor for our critical data science teams in India?
Apply now for the Senior Quality & Risk Management Lead position.
We are an equal opportunity employer committed to diversity and inclusion in the workplace.
