Are you an experienced Quality Assurance (QA) or Quality Control (QC) professional looking for a senior leadership role in Pakistan’s rapidly growing biotechnology and pharmaceutical industry? Searle Biopharma (formerly Nextar Pharma) is inviting applications for the position of Senior Lead Quality Operations (Biotech) at its Karachi Plant (Port Qasim).

This is a prestigious opportunity for professionals with over 10 years of experience in pharmaceutical or biotech quality management who possess strong expertise in Quality Management Systems (QMS), regulatory compliance, internal and external audits, quality operations, vendor qualification, and continuous improvement.

If you are passionate about ensuring product quality, regulatory excellence, and leading high-performing teams, this role offers an excellent platform to advance your career with one of Pakistan’s leading biotechnology organizations.

About Searle Biopharma

Searle Biopharma, formerly known as Nextar Pharma, is part of The Searle Company, a leading pharmaceutical organization in Pakistan. The company specializes in the research, development, and manufacturing of biotechnology and pharmaceutical products while maintaining international standards of quality, safety, and compliance.

Operating from its modern manufacturing facility at Port Qasim, Karachi, Searle Biopharma focuses on innovation, regulatory excellence, and continuous improvement to deliver safe and effective healthcare solutions.

Employees benefit from working in a professional environment that encourages innovation, leadership development, and adherence to globally recognized pharmaceutical standards.

Job Details

Job Overview

The Senior Lead Quality Operations (Biotech) will oversee the organization’s quality operations, ensuring that manufacturing and quality systems consistently comply with regulatory requirements, industry standards, and company policies.

The successful candidate will lead Quality Operations teams, establish quality objectives, monitor departmental KPIs, oversee vendor qualification activities, strengthen Quality Management Systems (QMS), and drive continuous improvement initiatives throughout the organization.

This strategic leadership role directly contributes to product quality, regulatory compliance, operational excellence, and patient safety.

Key Responsibilities

The selected candidate will be responsible for:

Quality Leadership

• Develop organizational quality objectives.
• Monitor departmental Key Performance Indicators (KPIs).
• Align quality goals with business objectives.
• Lead Quality Operations teams.
• Mentor and coach quality professionals.
• Build a culture of quality excellence.

Quality Management Systems (QMS)

• Ensure implementation of Quality Management Systems.
• Maintain compliance with GMP requirements.
• Strengthen quality documentation practices.
• Monitor effectiveness of QMS processes.
• Drive continual improvement initiatives.
• Ensure readiness for regulatory inspections.

Production Quality Oversight

• Ensure production complies with approved quality standards.
• Monitor manufacturing quality performance.
• Review quality trends.
• Investigate deviations.
• Support batch release activities.
• Coordinate with Production and Engineering departments.

Vendor Qualification

• Manage Vendor Qualification Programs.
• Evaluate supplier quality systems.
• Conduct vendor assessments.
• Monitor supplier performance.
• Ensure vendor compliance with regulatory expectations.
• Maintain approved supplier documentation.

Regulatory Compliance

• Ensure compliance with pharmaceutical regulations.
• Support local and international inspections.
• Lead internal quality audits.
• Manage regulatory observations.
• Implement corrective and preventive actions (CAPA).
• Ensure compliance with data integrity principles.

Health & Safety

• Ensure compliance with Health & Safety Management Systems.
• Support ISO and OHSAS requirements.
• Promote workplace safety culture.
• Monitor safety compliance within quality operations.

Employee Development

• Identify training requirements.
• Organize quality-related training programs.
• Develop team competencies.
• Conduct performance evaluations.
• Encourage professional development.
• Promote continuous learning.

Educational Requirements

Applicants should possess one of the following qualifications:

Required Qualification

• Pharm-D
• M.Phil. in Biochemistry
• M.Phil. in Organic Chemistry
• M.Phil. in Applied Chemistry

Additional certifications in pharmaceutical quality systems, GMP, ISO standards, Lean Six Sigma, or quality auditing will be considered an advantage.

Experience Requirements

Candidates should have:

• 10+ years of relevant experience.
• Experience in pharmaceutical or biotech industries.
• Strong Quality Assurance background.
• Practical exposure to Quality Control operations.
• Experience managing Quality Management Systems.
• Proven leadership experience.
• Regulatory audit experience.
• Vendor qualification expertise.
• Cross-functional collaboration experience.

Professionals with multinational pharmaceutical experience will have an added advantage.

Required Technical Skills

The ideal candidate should possess expertise in:

Quality Assurance

• Good Manufacturing Practices (GMP)
• Good Documentation Practices (GDP)
• Quality Risk Management (QRM)
• CAPA Management
• Deviation Investigations
• Change Control
• Root Cause Analysis

Quality Systems

• Quality Management System (QMS)
• ISO Standards
• OHSAS Requirements
• SOP Development
• Internal Auditing
• Quality Metrics
• Compliance Monitoring

Regulatory Knowledge

Candidates should understand:

• Pharmaceutical regulations
• Biotechnology quality standards
• Data Integrity (ALCOA+ principles)
• Regulatory inspections
• Validation concepts
• Vendor qualification requirements
• Documentation compliance

Analytical Skills

• Trend analysis
• KPI reporting
• Quality metrics analysis
• Statistical analysis
• Risk assessments
• Continuous improvement methodologies

Essential Leadership & Soft Skills

The successful candidate should demonstrate:

• Strategic leadership
• Team management
• Excellent communication skills
• Decision-making abilities
• Strong analytical thinking
• Problem-solving mindset
• Coaching and mentoring capabilities
• Time management
• Project management
• Conflict resolution
• Change management
• Business acumen

Understanding the Importance of Quality Operations in Biotech

Quality Operations is one of the most critical functions in biotechnology and pharmaceutical manufacturing. It ensures that products are consistently manufactured according to predefined quality standards, regulatory guidelines, and patient safety requirements.

Professionals in this field oversee:

• Manufacturing compliance
• Documentation systems
• Quality investigations
• Regulatory inspections
• Supplier quality
• Employee training
• Continuous improvement
• Risk management
• Product quality assurance

Their work directly impacts product reliability, regulatory approvals, and customer confidence.

Career Growth Opportunities

Joining Searle Biopharma can lead to senior leadership positions such as:

• Head of Quality Operations
• Senior Quality Assurance Manager
• Director Quality
• Site Quality Head
• Compliance Director
• Corporate Quality Manager
• Regulatory Compliance Director
• Vice President Quality
• Global Quality Systems Manager

The biotechnology sector continues to expand globally, creating excellent opportunities for experienced quality professionals.

Why Join Searle Biopharma?

Working at Searle Biopharma offers numerous professional benefits, including:

• Leadership opportunities in biotechnology
• Exposure to international regulatory standards
• Modern manufacturing technologies
• Continuous learning and development
• Participation in strategic quality initiatives
• Collaborative and innovation-driven workplace
• Opportunities to contribute to life-saving healthcare products

Tips for Preparing Your Application

To maximize your chances of selection:

• Update your CV with your latest leadership experience.
• Highlight achievements in Quality Assurance and Quality Control.
• Include successful audit experiences.
• Mention expertise in GMP, ISO, and QMS implementation.
• Demonstrate experience in vendor qualification programs.
• Highlight KPI management and quality improvement initiatives.
• Quantify achievements wherever possible, such as:
  • Reduction in quality deviations.
  • Successful regulatory inspections.
  • Improvements in audit scores.
  • Process optimization projects.
  • Employee training initiatives.
  • Quality performance improvements.

A results-oriented resume with measurable accomplishments will significantly strengthen your application.

How to Apply

Interested candidates who meet the eligibility criteria should send their updated resume to:

Email: [email protected]

Application Deadline

August 20, 2026

Email Subject Line

Quality Ops Biotech

Before submitting your application, ensure that your resume includes:

• Updated educational qualifications.
• Complete employment history.
• Leadership experience.
• Quality systems expertise.
• Audit and compliance achievements.
• Professional certifications.
• Key accomplishments with measurable business impact.

Final Thoughts

The Senior Lead Quality Operations (Biotech) position at Searle Biopharma is an exceptional opportunity for experienced pharmaceutical and biotechnology professionals who aspire to lead quality excellence within a world-class manufacturing environment.

This role combines leadership, regulatory compliance, quality management, continuous improvement, vendor qualification, and employee development, making it one of the most comprehensive senior quality positions available in Pakistan’s biotech sector.

If you possess 10+ years of Quality Assurance or Quality Control experience, a relevant scientific qualification, and a proven ability to lead teams while ensuring compliance with GMP, QMS, ISO, and regulatory standards, this opportunity can significantly elevate your professional career.

Frequently Asked Questions (FAQs)

1. What is the job title?

The position is Senior Lead Quality Operations (Biotech).

2. Where is the job located?

The role is based at Searle Biopharma’s Karachi Plant (Port Qasim).

3. What qualifications are required?

Candidates should have a Pharm-D or M.Phil. in Biochemistry, Organic Chemistry, or Applied Chemistry.

4. How much experience is needed?

Applicants must have 10+ years of relevant Quality Assurance or Quality Control experience within the pharmaceutical or biotech industry.

5. How do I apply?

Email your updated resume to [email protected] by August 20, 2026, mentioning “Quality Ops Biotech” in the subject line.