VaLogic Bio
Director, Operations – Boston
Boston, MA | Full-Time | On-Site
About VaLogic Bio
VaLogic Bio provides specialized advisory and compliance services that help life science and biotech companies stay GMP/GxP compliant—from facility concept through ongoing operations. Our integrated platform spans:
- GxP consulting and regulatory compliance services (GMP, GLP, GCP, USP, and DEA where applicable).
- Facility design and engineering, design-build support, commissioning, qualification, and validation (CQV).
- Calibration, environmental monitoring, testing, and certification services for cleanrooms, biosafety cabinets, and controlled environments.
- SaaS and technology solutions supporting asset management, temperature monitoring, and GxP operations.
Our Massachusetts office serves clients across New England with facility-focused, regulatory, and project management expertise tailored to complex life science environments.
The Opportunity
VaLogic Bio is expanding its presence in the New England life sciences market and is seeking a Director, Operations – Boston to lead our regional team and deepen relationships with biotech, pharma, cell & gene therapy, diagnostics, and medical device clients. This is a senior leadership role that blends hands-on GxP compliance expertise with team management and targeted business development engagement.
You will report to a senior VaLogic Bio executive and collaborate closely with peers across our Maryland, Texas, and other national locations.
What You'll Do
Team & Operations Leadership
- Lead, mentor, and grow a multidisciplinary team of consultants, engineers, project managers, and field service staff in the Boston/Massachusetts region.
- Own regional operational performance—including staff utilization, project delivery quality, and client satisfaction.
- Establish and reinforce standard operating procedures, best practices, and a culture of accountability and continuous improvement.
GxP Compliance Expertise
- Serve as the senior GxP compliance subject matter expert for the Boston office, advising clients on GMP facility design, qualification, operations readiness, and ongoing compliance strategies.
- Interpret and apply FDA GMPs, USP, ICH, ISO, and DEA standards across client engagements spanning Pharma, CGT, Biologics, Biosimilars, Generics, Diagnostics, and Medical Devices.
- Lead or contribute to key compliance deliverables: risk assessments, validation master plans, qualification protocols and reports, and inspection readiness plans.
- Stay ahead of evolving regulatory expectations and translate them into internal training and updated service offerings.
Service Delivery
- Coordinate delivery across all core VaLogic service lines—consulting, project management, CQV, calibration, environmental monitoring, and certification.
- Ensure seamless integration across advisory, facility, and lab services for a unified client experience from facility build-out through ongoing compliance.
- Collaborate with technology leaders to position and implement VaLogic's SaaS solutions for client asset management and compliance operations.
Business Development Support
- Partner with the sales and business development teams as a trusted technical resource in key pursuits, proposals, and client meetings.
- Represent VaLogic Bio at regional conferences, industry events, and thought-leadership activities within the Boston life sciences ecosystem.
What You'll Bring
Required
- 10+ years of experience in GxP-regulated life sciences (biotech, pharma, cell & gene therapy, sterile/aseptic operations, or related fields).
- At least 5 years in a leadership role overseeing technical or cross-functional teams.
- Deep, practical GMP knowledge with a track record in inspection readiness, remediation, or facility start-up.
- Experience managing teams delivering consulting, CQV, facility, or compliance services—internally or as an outsourced provider.
- Ability to communicate complex regulatory and technical concepts clearly to both technical experts and executive stakeholders.
Preferred
- Background spanning more than one VaLogic service domain: GxP compliance consulting, facility design/engineering or CQV, calibration/EM/certification, or compliance SaaS.
- Prior experience supporting sales or account growth as a technical SME or solutions architect.
- Familiarity with the Boston/New England life sciences ecosystem and regional requirements for specialized facilities (e.g., compounding, sterile manufacturing).
Location & Travel
- Primary location: Boston-area / Massachusetts office (on-site leadership role).
- Regular travel to client sites across New England.
- Occasional travel to other VaLogic Bio offices (e.g., Frederick, MD; Houston, TX).
Benefits
We currently offer a robust suite of employee benefits including:
Medical & Prescription Coverage Supplemental Life and AD&D
Dental Coverage Short and Long term Disability
Vision Coverage Employee Assistance Program
Health Savings Account (HSA) Unlimited Paid Time Off
Basic Life and AD&D 11 Paid Company Holidays
How to Apply
Interested candidates should submit a resume and brief cover letter outlining their relevant experience and interest in the role. VaLogic Bio is an equal opportunity employer committed to building a diverse and inclusive team.
VaLogic Bio · Boston, MA · valogicbio.com
No Unsolicited Resumes or Referrals
VaLogic Bio does not accept unsolicited resumes, candidate profiles, or communications from third-party recruiters, staffing agencies, or search firms. Any unsolicited submissions received will be considered the property of VaLogic Bio and no fee will be paid in the event a candidate is hired. Agencies wishing to engage with VaLogic Bio on a specific search must have a signed fee agreement in place prior to submitting candidates.
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