Quality Construction Lead

Location: Central IndianaEngagement Type: Contract (W2 or 1099)Target Start: August / September 2026Experience Required: 20+ years requiredCompensation: Competitive hourly compensation commensurate with experience. Rate structure (W2 or 1099) determined at time of engagement. Compensation reflective of seniority, scope complexity, and program criticality.Position OverviewPlanet Pharma is seeking a senior Quality Construction Lead to support a large-scale pharmaceutical capital program in Central Indiana. This is an owner's representative leadership role responsible for overseeing all construction quality activities across a GMP pharmaceutical manufacturing facility. The ideal candidate brings 20+ years of capital construction and quality management experience in pharma or other regulated industries, with deep expertise in GMP construction quality systems, inspection programs, and construction-to-commissioning quality handover.Key ResponsibilitiesLead the owner's construction quality program across all disciplines including CSA, mechanical, piping, E&I, and HVAC scopesDevelop, implement, and maintain construction quality plans, inspection and test plans (ITPs), and quality surveillance programs in alignment with GMP requirementsConduct and oversee field quality inspections, material verifications, and construction surveillance activitiesReview and approve contractor quality documentation including ITPs, NCRs, material traceability records, and weld inspection reportsManage the non-conformance report (NCR) process including identification, documentation, evaluation, and resolution trackingInterface with commissioning and validation teams to ensure construction quality documentation supports downstream qualification activitiesLead construction quality audits of contractor quality systems and field executionEnsure all welding activities, including orbital and manual welds on hygienic and utility piping, meet applicable code and project standardsSupport development of turnover packages and ensure quality documentation is complete and accurate at mechanical completionEnsure compliance with FDA facility guidelines, ASME codes, and applicable regulatory standards throughout constructionRequirements & Qualifications20+ years of experience in construction quality management on large capital programs — REQUIREDDirect GMP pharmaceutical or biotech capital project quality experience strongly preferredDemonstrated owner's representative or client-side construction quality leadership on programs of $100M+Deep knowledge of GMP construction quality systems, ITP development, NCR management, and material traceability requirementsStrong expertise in welding inspection standards (ASME BPE, ASME B31.3) for pharmaceutical piping and process systemsExperience coordinating quality documentation with commissioning, qualification, and validation teamsWorking knowledge of FDA 21 CFR Part 211, cGMP facility requirements, and construction quality expectations in regulated environmentsCWI (Certified Welding Inspector) certification strongly preferred; CQIA or ASQ certification a plusOSHA 30 certification required; BS in Engineering, Quality, or related discipline preferredAbility to work full-time on-site in Central Indiana