Quality Construction Lead

• Location: Central Indiana
• Engagement Type: Contract (W2 or 1099)
• Target Start: August / September 2026
• Experience Required: 20+ years required
• Compensation: 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 OVERVIEW

Planet 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 RESPONSIBILITIES

• Lead the owner’s construction quality program across all disciplines including CSA, mechanical, piping, E&I, and HVAC scopes

• Develop, implement, and maintain construction quality plans, inspection and test plans (ITPs), and quality surveillance programs in alignment with GMP requirements

• Conduct and oversee field quality inspections, material verifications, and construction surveillance activities

• Review and approve contractor quality documentation including ITPs, NCRs, material traceability records, and weld inspection reports

• Manage the non-conformance report (NCR) process including identification, documentation, evaluation, and resolution tracking

• Interface with commissioning and validation teams to ensure construction quality documentation supports downstream qualification activities

• Lead construction quality audits of contractor quality systems and field execution

• Ensure all welding activities, including orbital and manual welds on hygienic and utility piping, meet applicable code and project standards

• Support development of turnover packages and ensure quality documentation is complete and accurate at mechanical completion

• Ensure compliance with FDA facility guidelines, ASME codes, and applicable regulatory standards throughout construction

REQUIREMENTS & QUALIFICATIONS

• 20+ years of experience in construction quality management on large capital programs — REQUIRED

• Direct GMP pharmaceutical or biotech capital project quality experience strongly preferred

• Demonstrated 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 requirements

• Strong expertise in welding inspection standards (ASME BPE, ASME B31.3) for pharmaceutical piping and process systems

• Experience coordinating quality documentation with commissioning, qualification, and validation teams

• Working knowledge of FDA 21 CFR Part 211, cGMP facility requirements, and construction quality expectations in regulated environments

• CWI (Certified Welding Inspector) certification strongly preferred; CQIA or ASQ certification a plus

• OSHA 30 certification required; BS in Engineering, Quality, or related discipline preferred

• Ability to work full-time on-site in Central Indiana