Assistant General Manager QA

4 weeks ago

Ahmedabad, India Biotech Healthcare Full time

Role Objective:

A key objective of this position is to design, implement and enhance organizational work practices that align with quality management principles. Role will focus on establishing a culture of continuous improvement, compliance and operational excellence within the organization. Role involves the development and maintenance of a Quality Management System (QMS), managing training initiatives and driving projects related to quality and regulatory compliance within the medical device sector.


Desired Candidate Profile:

  • Detail-oriented professional with 10 to 12 years of experience in Quality Assurance or related fields, preferably within the Medical Device Industry.
  • Strong understanding of regulatory requirements, including FDA, ISO 13485, GMP and GDP.
  • Proven expertise in developing and implementing QMS processes, handling compliance and conducting internal audits.
  • Demonstrated ability to lead quality-based projects and manage cross-functional teams.
  • Excellent communication and leadership skills, with a track record of successful project management and stakeholder engagement.


Responsibilities:

Quality Management System (QMS) Development:

  • Design, implement, and maintain a robust QMS framework in line with regulatory requirements and industry standards.
  • Authorize and review SOPs, master documents, and quality protocols, ensuring comprehensive compliance across all operational processes.

Compliance & Documentation:

  • Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
  • Ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.
  • Conduct document reviews for new product launches, ensuring alignment with regulatory requirements.

Audit & Risk Management:

  • Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
  • Investigate quality-related issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).

Project Leadership:

  • Drive quality improvement projects and initiatives, collaborating with multidisciplinary teams to enhance operational efficiency and compliance.
  • Act as the Management Representative (MR) for quality reviews, planning and conducting Management Review Meetings (MRM), and following up on action items.

Business Continuity & Process Improvement:

  • Support the business continuity management plan, ensuring seamless operations during disruptions.
  • Continuously monitor and improve QMS activities, including change control, deviation management, and CAPA implementation.

Training & Development:

  • Identify training needs across departments and design comprehensive training programs on GMP, QMS, and regulatory compliance.
  • Implement and manage online training systems, ensuring consistent knowledge dissemination and compliance awareness among staff.


Functional Skills Required:

  • Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance.
  • Proficiency in managing quality projects, conducting internal audits, and performing gap analyses.
  • In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations.
  • Ability to lead and manage cross-functional teams effectively.
  • Competence in conducting training programs and implementing quality improvement initiatives.


Behavioral Skills Required:

  • Leadership and Team Management: Ability to guide, motivate, and develop team members towards achieving organizational goals.
  • Attention to Detail: High level of precision in reviewing documents, managing audits, and ensuring compliance.
  • Problem-Solving & Analytical Thinking: Strong capability to identify issues, analyze root causes, and implement effective solutions.
  • Communication & Interpersonal Skills: Excellent communication skills, with the ability to interact effectively with stakeholders at various levels.
  • Adaptability & Change Management: Ability to adapt to changing business needs and lead initiatives for continuous improvement.


Team Size to be Handle:

  • Manage a team size of over 12 to 15 QA professionals, reporting directly to the Vice President of Corporate Quality.


Learn more at:


Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

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