Head Corporate Quality

Job Title: Corporate Quality Assurance Head

Location:

Position Level:

Responsibilities:

1. Quality Management System Leadership:

• Develop, implement, and oversee the Corporate Quality Management System for injectables, oral solid dosage formulations, and active pharmaceutical ingredients (APIs).
• Ensure compliance with global regulatory standards and industry best practices.

2. Regulatory Compliance:

• Stay abreast of global regulatory requirements for pharmaceutical manufacturing, ensuring the company's adherence to guidelines for injectables, oral solid dosage formulations, and APIs.
• Represent the company during regulatory inspections and audits.

3. Quality Assurance Strategy:

• Develop and execute a comprehensive Quality Assurance strategy aligned with the company's business objectives.
• Implement robust processes for quality control, risk management, and continuous improvement.

4. Cross-functional Collaboration:

• Collaborate with cross-functional teams, including Production, R&D, Regulatory Affairs, and Supply Chain, to ensure quality integration throughout the product lifecycle.
• Provide guidance on quality-related matters to various departments.

5. Quality Metrics and Reporting:

• Establish key quality performance indicators (KPIs) and metrics.
• Prepare and present regular reports to executive leadership on the status of quality initiatives, compliance, and performance against quality objectives.

6. Audit Management:

• Lead and manage internal and external audits for manufacturing facilities, ensuring compliance with cGMP, ICH, and other applicable standards.
• Develop and implement corrective and preventive action plans.

7. Quality Training Programs:

• Develop and implement comprehensive training programs to ensure all employees are knowledgeable about quality standards, procedures, and compliance requirements.
• Conduct regular training sessions for relevant staff.

8. Supplier Quality Management:

• Implement a robust Supplier Quality Management program, including the evaluation and qualification of suppliers for raw materials and components.
• Ensure that suppliers adhere to quality standards and meet regulatory requirements.

9. Change Control and Deviation Management:

• Oversee the Change Control and Deviation Management processes, ensuring timely assessment, documentation, and resolution of deviations and changes.
• Implement effective preventive action plans.

10. Validation and Qualification:

• Lead validation and qualification activities for manufacturing processes, equipment, and facilities.
• Ensure compliance with validation protocols and documentation requirements.

Requirements:

1. Education:

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field. Advanced degree is a plus.

2. Experience:

• Minimum 15 years of experience in Quality Assurance within the pharmaceutical industry, with expertise in injectables, oral solid dosage formulations, and APIs.
• Proven track record of successfully managing QA functions at a corporate level.

3. Leadership Skills:

• Strong leadership and people management skills with a focus on building and leading a high-performing QA team.
• Ability to drive a culture of quality and compliance throughout the organization.

4. Regulatory Knowledge:

• In-depth knowledge of global regulatory requirements for pharmaceutical manufacturing, including USFDA, EU , EMA, and other regulatory agencies.
• Experience with regulatory inspections and audits.

5. Strategic Thinking:

• Demonstrated ability to develop and execute strategic plans for Quality Assurance, contributing to the overall success of the organization.

6. Communication Skills:

• Excellent communication and interpersonal skills with the ability to convey complex quality concepts to diverse audiences.

7. Analytical Skills:

• Strong analytical and problem-solving skills with the ability to interpret quality data and trends.

8. Change Management:

• Experience in managing change control processes and driving a culture of continuous improvement.