Role Objective:
A key objective of this profile is to lead and strengthen the Corporate Quality Assurance (CQA) function by ensuring the effective implementation and continuous improvement of the Quality Management System (QMS) across all manufacturing sites. The position is responsible for maintaining compliance with global regulatory standards, providing corporate quality oversight, driving audit readiness, and fostering a strong quality culture throughout the organization.
Desired Candidate Profile:
- Master's or bachelor's degree in pharmacy, life sciences, biotechnology, or a related discipline.
- 1822 years of experience in quality assurance within regulated pharmaceutical or healthcare manufacturing environments.
- Proven experience in corporate quality functions and handling global regulatory inspections.
- Strong understanding of GMP regulations and international regulatory expectations.
- Experience in multi-site quality oversight and corporate quality management.
Role & Responsibilities:
1. Quality Management System (QMS)
- Lead and maintain the corporate quality management system in alignment with global regulatory requirements and internal quality standards.
- Ensure effective implementation of QMS elements such as CAPA, change control, deviations, OOS/OOT, and risk management across all manufacturing locations.
- Standardize and harmonize quality processes, procedures, and documentation across sites.
- Monitor quality metrics and drive continuous improvements in quality systems.
2. Regulatory Compliance
- Ensure organizational compliance with international regulatory requirements, including USFDA, EU GMP, WHO GMP, MHRA, and other applicable regulatory authorities.
- Track and interpret regulatory updates and ensure timely implementation within the organization.
- Support regulatory submissions and maintain a strong state of inspection readiness across facilities.
3. Corporate Quality Oversight
- Provide strategic quality oversight to all manufacturing plants and ensure adherence to corporate quality policies and procedures.
- Review and approve critical quality documents, quality systems, and compliance reports.
- Conduct periodic corporate quality reviews and monitor site performance through defined quality metrics.
4. Audits & Inspections
- Plan, coordinate, and conduct internal audits, corporate audits, and vendor audits to ensure compliance with GMP and regulatory standards.
- Lead preparation activities for regulatory inspections and customer audits.
- Review audit findings and ensure timely implementation of corrective and preventive actions.
5. Continuous Improvement
- Drive initiatives to strengthen quality culture and operational excellence across the organization.
- Implement risk-based approaches for quality decision-making and compliance management.
- Lead cross-functional quality improvement projects aimed at enhancing efficiency and compliance.
6. Team Leadership & Cross-Functional Collaboration
- Mentor and guide site QA teams to ensure effective implementation of quality systems and best practices.
- Collaborate with cross-functional teams including Manufacturing, Quality Control (QC), Regulatory Affairs, Engineering, and Supply Chain to ensure quality alignment.
- Promote knowledge sharing and capability development within the quality organization.
Functional Skills Required:
- Strong expertise in Quality Management Systems (QMS) and GMP compliance.
- In-depth knowledge of CAPA, deviations, change control, OOS/OOT investigations, and risk management.
- Experience in regulatory audit preparation and management.
- Proficiency in quality documentation systems and compliance monitoring tools.
- Ability to analyze quality metrics and implement data-driven improvements.
Behavioral Skills Required:
- Strong leadership and team management abilities.
- Excellent analytical and problem-solving skills.
- Effective communication and stakeholder management.
- Strategic thinking and decision-making capabilities.
- High level of integrity, accountability, and attention to detail.
Team Size to be Handle:
- Reports to: VP Corporate Quality
- Team Structure: Manage a team size of over 12 to 15 QA professionals.
Important Links:
- Website: https://biotechhealthcare.com/
- LinkedIn: https://www.linkedin.com/company/biotechhealthcare/
- Instagram: Biotech Vision Care
Learn more at: https://www.biotechhealthcare.com
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.
