Director of Operations- Boston

VALOGIC BIO LLC•Avon, MA

1d•$150,000 - $190,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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).

Responsibilities

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.
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.
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.
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.