Biotech Network Advisor, Quality Assurance

Ladders; United States; Remoto; USD 110.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Full-time position

Limited travel

Impact on capital projects

Cross-functional collaboration

Descrizione del lavoro

Ladders is seeking a Biotech Network Advisor, Quality Assurance to join a leader in Pharmaceuticals & Biotech. The role serves as the QA partner on capital projects, embedding quality from design through validation.

The advisor will collaborate with project teams, technical leaders, and quality stakeholders to ensure compliant execution, documentation, and ongoing process improvement across design, development, commissioning, qualification, and validation activities.

Competenze

• Bachelor's degree in a science or engineering discipline.
• 10+ years of quality, engineering, or validation experience in a regulated industry.
• Thorough knowledge of cGMPs, FDA, USDA, and EU regulations related to manufacturing and quality.
• Strong leadership and organizational skills with high attention to detail.
• Analytical mindset focused on process improvement.
• Clinical research and development experience is highly preferred.

Mansioni

• Act as the Quality Assurance representative for capital project activities.
• Participate in design, development, commissioning, qualification, and validation activities.
• Assist in defining Quality Control testing laboratory needs and compliance requirements.
• Ensure compliance with USDA, FDA, and EMA regulations during project execution.
• Serve as a QA subject matter expert on project teams.
• Review and approve documentation including specifications and validation plans.
• Support the creation and implementation of quality standards and continuous business process improvement.

Conoscenze

Quality Assurance leadership

Regulatory knowledge

Process improvement

Project coordination

Formazione

Bachelor's degree in science or engineering

Strumenti

Regulatory frameworks

Descrizione del lavoro

For our client, we are seeking a Biotech Network Advisor, Quality Assurance to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will serve as the Quality Assurance partner on capital projects, helping ensure quality and compliance are embedded from design through validation. The position will work closely with project teams, technical leaders, and quality stakeholders to support compliant execution, documentation, and ongoing process improvement. It is well suited for a seasoned QA professional who can bring regulatory insight and practical leadership to complex biopharmaceutical initiatives.

The work will focus on major capital project activities, including design, development, commissioning, qualification, and validation. The advisor will help define quality control laboratory requirements, review key project documentation, and reinforce compliance with global regulatory expectations throughout execution.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $110,000 – $130,000 annually

Responsibilities

• Act as the Quality Assurance representative for capital project activities
• Participate in design, development, commissioning, qualification, and validation activities
• Assist in defining Quality Control testing laboratory needs and compliance requirements
• Ensure compliance with USDA, FDA, and EMA regulations during project execution
• Serve as a QA subject matter expert on project teams
• Review and approve documentation including specifications and validation plans
• Support the creation and implementation of quality standards and continuous business process improvement

Qualifications

• Bachelor's degree in a science or engineering discipline
• 10+ years of quality, engineering, or validation experience in a regulated industry
• Thorough knowledge of cGMPs, FDA, USDA, and EU regulations related to manufacturing and quality
• Strong leadership and organizational skills with high attention to detail
• Analytical mindset focused on process improvement
• Clinical research and development experience is highly preferred

Benefits

• Full-time permanent position with minimal travel requirements
• Opportunity to influence quality and compliance in major capital projects
• Collaborate with cross-functional teams and strengthen leadership skills
• Contribute to quality assurance in cutting-edge biopharmaceutical projects

Our client is an equal opportunity employer.