Role Objective

A key objective of this position is to ensure adherence to global regulatory standards and best practices while maintaining robust quality systems. The role focuses on implementing effective quality processes, driving continuous improvement initiatives, and fostering a strong culture of compliance to guarantee the safety, efficacy, and quality of injectable products.

Desired Candidate Profile

M.Sc. / M.Pharm / B.Pharm / B.E. in Life Sciences or Engineering.
Minimum 16+ years of relevant leadership experience in Quality Assurance, including Site Quality leadership.
At least 10+ years of experience in supervising, managing, and directing teams.
Demonstrated knowledge of cGMPs, global health authority regulations and guidelines, and Quality Management Systems.
Strong technical expertise with proven ability to lead quality operations in a fast-paced manufacturing environment.
Excellent interpersonal, leadership, and stakeholder management skills.

Role & Responsibilities

Lead the Quality Assurance function across the site, ensuring compliance with global regulations and internal quality standards.
Establish, monitor, and enhance Quality Management Systems to ensure operational excellence.
Partner with Site Operations, Regulatory Affairs, Clinical Operations, and Finance to align quality objectives with business goals.
Ensure timely review and approval of validation protocols, master manufacturing records, deviations, CAPAs, and change controls.
Oversee audits and inspections by regulatory authorities and ensure prompt and effective closure of observations.
Drive continuous improvement initiatives to enhance product quality and operational efficiency.
Develop, mentor, and lead a high-performing QA team by fostering accountability, innovation, and learning.
Ensure effective training of personnel on quality systems, regulatory requirements, and company policies.
Support risk management and decision-making processes to uphold product quality and patient safety.

Functional Skills Required

Strong understanding of cGMP regulations and global quality guidelines.
Proficiency in Quality Management Systems, audit processes, and risk-based approaches.
Ability to evaluate technical and scientific data for decision-making.
Expertise in deviation management, CAPA systems, and change control processes.
Knowledge of aseptic manufacturing and injectable product quality standards.
Competency in leading regulatory inspections and managing compliance requirements.

Behavioral Skills Required

Strong leadership presence with the ability to influence at all levels of the organization.
Analytical and logical reasoning skills with a solution-oriented mindset.
High sense of urgency with a focus on timely and effective decision-making.
Collaborative approach, fostering cross-functional teamwork and alignment.
Resilience and ability to manage complex challenges while maintaining focus on long-term goals.
Commitment to building and nurturing a culture of quality, compliance, and continuous improvement.

Team Size to be Handled:

Lead and supervise a team of 13-15 team members, reporting to the VP – Corporate Quality.

Important Links:

Website:https://biotechhealthcare.com/
LinkedIn:https://www.linkedin.com/company/biotechhealthcare/
Instagram:Biotech Vision Care

Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.

General Manager - Quality Assurance (Injectable)