Senior CQV Consultant & Project Quality Manager

NNE; Clayton (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

160 hours PTO

Health, dental, and vision insurance

8% guaranteed 401(k) company contrib.

Parental leave

Life and disability insurance

Employee referral bonuses

Job summary

NNE in the United States seeks an Advanced CQV Consultant to lead commissioning, qualification, and validation activities across complex life sciences projects. Serving as Project Quality Manager on assigned projects, you will drive validation strategies that meet client, industry, and regulatory requirements while guiding multidisciplinary teams.

You will collaborate with engineering, automation, quality, and manufacturing groups, develop CQV lifecycle documents, manage risk, scope changes, and

Qualifications

• 8+ years of CQV, Quality, Validation, or GMP consulting experience in pharma/biotech.
• Experience leading qualification and validation programs for GMP facilities.
• Knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, ISPE Guides, and Data Integrity.

Responsibilities

• Plan, execute, and deliver CQV activities for pharma/biotech projects.
• Serve as PQM on small to mid-sized projects, managing validation deliverables.
• Develop and review CQV lifecycle documentation and risk assessments.
• Collaborate with engineering, automation, quality, and manufacturing teams.
• Mentor junior consultants and support business development activities.

Skills

CQV leadership

Quality management

Regulatory compliance

Client relationships

Proposal development

Education

Bachelor's or Master's in Engineering/Life Sciences/Pharma

Job description

NNE in the United States seeks an Advanced CQV Consultant to lead commissioning, qualification, and validation activities across complex life sciences projects. Serving as Project Quality Manager on assigned projects, you will drive validation strategies that meet client, industry, and regulatory requirements while guiding multidisciplinary teams.

You will collaborate with engineering, automation, quality, and manufacturing groups, develop CQV lifecycle documents, manage risk, scope changes, and