Validation & Compliance Lead - Risk-Based C&Q for Biopharma

Valspec; Boston (MA); On-site; USD 140,000 - 230,000; Full time

Benefits offered by this job

ESOP

Premium medical coverage

401(k) with company match

Tuition reimbursement

Performance incentives

Job summary

Valspec is seeking a Validation & Compliance Lead to steer risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program on the East Coast. You will guide the program's qualification philosophy and ensure data integrity across projects.

As a senior leader, you will interface with QA and regulatory stakeholders, drive ASTM E2500 implementation, and ensure inspection readiness and documentation compliance for large capital pharma initiatives.

Qualifications

• GAMP and DeltaV qualification background required.
• Proven risk-based C&Q leadership on greenfield biologics/pharma projects.
• Experience with large capital pharma or biotech project delivery.

Responsibilities

• Provide validation strategy and compliance leadership.
• Drive risk-based validation approaches and ASTM E2500 implementation.
• Interface with quality and regulatory stakeholders.
• Ensure inspection readiness and documentation compliance.
• Lead qualification philosophy and data integrity alignment across the program.

Skills

GAMP

DeltaV qualification

Regulatory risk management

C&Q leadership

Job description

Valspec is seeking a Validation & Compliance Lead to steer risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program on the East Coast. You will guide the program's qualification philosophy and ensure data integrity across projects.

As a senior leader, you will interface with QA and regulatory stakeholders, drive ASTM E2500 implementation, and ensure inspection readiness and documentation compliance for large capital pharma initiatives.