Assistant General Manager QA (Medical Device)

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 15 to 18 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.

A minimum of 4 to 5 years of Medical Device QA experience will be advantageous.

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