Senior Consultant, Quality

Syner-G BioPharma Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Syner-G BioPharma Group is seeking a Senior Consultant in Quality to lead quality events evaluation and GMP auditing. This role requires extensive experience in FDA inspections and the pharmaceutical industry, focusing on regulatory compliance and quality systems. Join a leading consultancy recognized for its positive work environment and commitment to employee growth.

Benefits

Competitive salary

Benefits

Remote work options

Development opportunities

Supportive culture

Qualifications

• 2-5+ years FDA inspection experience required.
• 10+ years in the pharmaceutical industry.
• Strong knowledge of CFR regulations and quality systems.

Responsibilities

• Lead GMP auditing of manufacturing facilities.
• Develop and maintain the client’s Quality System.
• Manage pre-approval inspections and internal audits.

Skills

Project Management

Stakeholder Management

Communication

Leadership

Critical Thinking

Education

Bachelor's degree in biology, biochemistry, chemical engineering, or relevant discipline

Job description

Join to apply for the Senior Consultant, Quality role at Syner-G BioPharma Group

Company Description

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance, and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum.

We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations.

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of drug discovery, approval, product development, technology transfer, and commercial manufacturing. We also equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs, making a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment, emphasizing culture, career growth, development opportunities, financial rewards, leadership, and innovation.

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

Position Overview

The Senior Consultant, Quality leads the evaluation of quality events, incidents, and possible complaints, and the follow-up of such events. Perform / Lead GMP auditing of manufacturing facilities of clients, vendors, and internal operations. Ensure that the CMC Quality vertical works seamlessly with Syner-G’s Technical group, Regulatory Affairs, CMC leads, and others, as well as key external parties. The Sr Consultant will operate independently, managing day-to-day operations with minimal input or support needed.

WORK LOCATION: This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required (Up to 25%).

Job Functions

• Lead and work individually in the Quality vertical, serving as the primary contact for clients.
• Collaborate with manufacturing, CMC Technical, and Regulatory teams to meet client needs.
• Review and approve SOPs, product specifications, batch records, and annual quality reports.
• Develop, implement, and maintain the client’s Quality System, facilitating process improvements.
• Lead/support quality system reviews, deviations, OOS, CAPAs, and remediation plans.
• Review batch records, COAs, stability data, and regulatory documentation.
• Manage pre-approval inspections and internal audits.
• Build and support the quality vertical for Syner-G.
• Serve as a subject matter expert in facility cleanroom design and provide guidance.
• Act as liaison between clients and CMOs/contract labs.
• Approve documents for clinical trials, create COAs, and support regulatory submissions.
• Influence and guide clients through decision-making using strong problem-solving and comprehensive drug development knowledge.

Qualifications And Requirements

Must have a bachelor’s or higher degree in biology, biochemistry, chemical engineering, or relevant discipline. Require 2-5+ years FDA inspection experience and 10+ years in the pharmaceutical industry. Experience with GMP inspections, FDA practices, and regulatory compliance is essential. Strong knowledge of CFR regulations, quality systems, and risk-based approaches is necessary.

Knowledge, Skills, And Abilities

• Strong QMS knowledge, project management, and stakeholder management skills.
• Excellent communication, organizational, leadership, and critical thinking abilities.
• Ability to work independently, adapt, and develop creative solutions.

Essential Functions

Includes physical demands such as computer use, walking, sitting, and occasional standing or stooping. The work environment is typical of an office setting with moderate noise and bright lighting.

Total Rewards

Includes competitive salary, benefits, remote work options, development opportunities, and a supportive culture. Locations include Greater Boston, Boulder, CO, and Chennai, India.

Legal Statement

We are committed to equal employment opportunity and affirmative action. All employment decisions are made without regard to race, color, religion, sex, or other protected categories. We are an E-Verify employer.