Position Summary:
We are seeking a highly experienced and assertive Senior Position of Product Quality to lead our Quality function across biotech/pharmatech operations. This role requires a mature professional (preferably between10- 15 years experience) with strong leadership, technical expertise, and the ability to influence and push initiatives forward. This Position of Product Quality will ensure that all products meet the highest standards of safety, efficacy, and compliance with global regulatory requirements.
Key Responsibilities:
- Lead and oversee end-to-end Quality Management Systems (QMS), ensuring compliance with ISO and other relevant regulatory standards.
- Drive quality assurance, quality control, product testing, and release processes for biotech/pharmatech products.
- Establish a culture of quality and continuous improvement, embedding strong processes across manufacturing, R&D, supply chain, and product lifecycle.
- Build, mentor, and lead a high-performing quality team with accountability and discipline.
- Partner with cross-functional Senior Poistions (Production, R&D, Supply Chain, Regulatory Affairs) to align business goals with quality objectives.
- Ensure proactive risk identification, root cause analysis, and implementation of corrective & preventive actions (CAPA).
- Drive quality metrics, dashboards, and review mechanisms with senior leadership to monitor product quality performance.
- Take assertive action when quality standards are at risk, ensuring product integrity and patient safety at all times.
Candidate Profile:
- Experience: Minimum 10–15 years in biotech/pharma tech quality management, with at least 5 years in a senior leadership role.
- Education: B.Pharm / M.Pharm / M.Sc (Biotech, Microbiology, Life Sciences) / Ph.D Proven track record of handling audits ISO etc.) and regulatory interactions.
- Strong leadership presence – mature, assertive, and able to influence and push initiatives forward.
- Excellent knowledge of quality compliance frameworks and global pharma/biotech standards.
- Strategic mindset with hands-on problem-solving ability.
Key Competencies:
- Assertive decision-making and leadership.
- Strong regulatory and compliance acumen.
- High integrity and commitment to patient safety & product quality.
- Excellent communication and cross-functional collaboration.
- Ability to push for results while maintaining team alignment and morale.
Why Join Us:
- Opportunity to lead the Quality function in our company.
- A strategic role with direct impact on product quality, compliance, and global reputation.
- Work with a leadership team committed to innovation, compliance, and excellence.
Preferably, the candidate should be a resident of Ambala or within 30KM.