Validation & Compliance Lead

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-a global provider of system validation and lifecycle services-a provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

About the Role

We're hiring a Validation & Compliance Lead to drive risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program.

What You'll Do

• 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

What We're Looking For

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

Location

East Coast (site-specific details shared during interview process)

Why Join Valspec?

At Valspec, we offer more than just a job - we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more - all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.