Quality Lead - Pharmaceutical Manufacturing Facility Construction

Job Description

Job Description

We are seeking an experienced Quality Lead to oversee and manage the quality program for the construction of a pharmaceutical manufacturing facility in San Francisco, CA. The Quality Lead will lead a team responsible for ensuring that engineering, construction, testing, inspection, documentation, and project closeout activities are executed in accordance with approved design documents, project specifications, applicable codes and standards, and pharmaceutical industry quality requirements.

The successful candidate will work closely with engineering, design, construction, commissioning, validation, contractors, subcontractors, and third-party inspection organizations to identify and resolve quality issues early, maintain strong quality controls throughout construction, and ensure the facility is delivered in a complete and documented condition.

Key Responsibilities

Design Phase Quality

• Lead the quality team in reviewing engineering drawings, specifications, architectural plans, and other design deliverables.
• Identify potential design conflicts, constructability issues, omissions, and errors before construction activities begin.
• Establish project-specific inspection and test plans, inspection points, hold points, witness points, and acceptance criteria.
• Coordinate with engineering and design teams regarding materials, equipment, construction methods, and quality requirements.
• Participate in design reviews and provide quality-focused input to support constructability and long-term facility performance.
• Ensure quality requirements are clearly communicated and incorporated into construction documents and contractor scopes.
• Support the development of quality procedures, standards, and processes appropriate for a pharmaceutical manufacturing environment.

Construction Phase Quality

• Lead and manage the project quality team, including quality engineers, inspectors, and other quality personnel.
• Conduct or oversee daily site quality inspections and audits to verify compliance with approved drawings, specifications, procedures, and applicable requirements.
• Coordinate and manage third-party testing agencies, special inspectors, laboratories, and other inspection resources.
• Monitor construction activities and identify defective, nonconforming, or potentially unsafe work.
• Have the authority to escalate and, when necessary, stop work that presents significant quality, compliance, or safety concerns until appropriate corrective action is established.
• Manage nonconformance reports, corrective actions, observations, deficiencies, and quality-related issues through timely resolution.
• Track corrective actions to closure and verify that completed work meets specified acceptance criteria.
• Work collaboratively with contractors and subcontractors to establish root causes and prevent recurrence of quality issues.
• Participate in construction meetings, quality meetings, inspections, and coordination sessions with project stakeholders.
• Ensure inspection and testing activities are completed at required stages of construction and that results are properly documented.

Documentation, Turnover & Closeout

• Review and maintain quality records, including weld logs, welder qualifications, concrete testing records, material certificates, inspection reports, test results, and other required documentation.
• Ensure quality documentation is complete, accurate, traceable, and maintained in accordance with project requirements.
• Maintain official quality files and records throughout the design, procurement, construction, testing, and closeout phases.
• Monitor contractor quality documentation and verify that required records are submitted and accepted.
• Support the development and completion of project punch lists and deficiency logs.
• Coordinate with construction, commissioning, engineering, and project teams to ensure quality-related punch-list items are resolved prior to final handover.
• Support final turnover and acceptance activities by ensuring required quality documentation and records are complete and properly organized.
• Contribute to lessons learned and continuous improvement activities at project completion.

Team Leadership

• Manage, mentor, and develop the project quality team.
• Establish clear responsibilities, performance expectations, and inspection priorities for quality personnel.
• Allocate quality resources based on construction activities, project risk, and inspection requirements.
• Promote a proactive quality culture focused on preventing defects rather than simply identifying them after the fact.
• Serve as the primary quality point of contact for project leadership, contractors, consultants, and third-party inspection organizations.
• Escalate significant quality risks and trends to project leadership with clear recommendations for corrective action.

Qualifications

• Bachelor's degree in Engineering, Construction Management, Quality, or a related technical discipline preferred.
• 8+ years of construction quality experience , preferably on large-scale industrial, pharmaceutical, life sciences, biotech, semiconductor, advanced manufacturing, or similarly regulated facilities.
• Demonstrated experience leading a construction quality team on a major capital project.
• Strong understanding of construction inspection, testing, quality control, and quality assurance processes.
• Experience reviewing engineering drawings, specifications, material submittals, inspection plans, and construction documentation.
• Experience managing third-party testing agencies, inspectors, laboratories, and specialty contractors.
• Strong knowledge of construction quality documentation, nonconformance management, corrective actions, and project closeout.
• Experience with pharmaceutical or other highly regulated manufacturing environments is strongly preferred.
• Familiarity with GMP-related facility expectations, commissioning/qualification interfaces, and regulated manufacturing environments is highly desirable.
• Strong communication, leadership, organizational, and problem-solving skills.
• Ability to work effectively with engineering, construction, commissioning, validation, contractors, and project management teams.

Preferred Certifications

One or more of the following certifications or credentials is preferred:

• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• Certified Construction Quality Professional or equivalent
• AWS Certified Welding Inspector (CWI), where applicable
• ICC inspection certifications, where applicable
• LEED or other relevant construction/facility certifications

Core Competencies

• Construction Quality Management
• Quality Assurance / Quality Control
• Pharmaceutical & Life Sciences Construction
• Inspection & Testing
• Nonconformance Management
• Corrective and Preventive Actions
• Document Control
• Contractor Quality Management
• Third-Party Inspection Management
• Design & Constructability Review
• Risk-Based Quality Planning
• Team Leadership
• Project Closeout & Turnover
• Strong Written and Verbal Communication

Working Environment

This position will be primarily based at an active construction site in San Francisco, California , and will require regular presence in the field to observe construction activities, conduct inspections, coordinate with contractors, and lead the project quality team. The role may require extended periods on an active construction site, including appropriate personal protective equipment and adherence to site safety requirements.

Success in This Role

Success in this position will be demonstrated by a proactive quality program that identifies issues before they become costly rework, maintains strong control of inspection and testing activities, ensures timely resolution of deficiencies, and delivers a complete, accurate, and traceable quality record for facility handover.

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architect, engineering, and construction firm. Our company delivers the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.

The AM core foundation was built on quality programs that optimized semiconductor facility operations. As the company developed, AM added core competencies on pre-construction, procurement, and construction. Further, through strategic acquisitions, we added design, commissioning, and validation to create a complete end-to-end solution for high-tech construction project delivery.

AMTS AE is a licensed Engineering and Architecture, Business Unit of AM Technical Solutions. At AMTS AE, we focus on providing design and consulting services for advanced technology, government, university, and industrial clients, specializing in research, pilot lines, manufacturing, cleanrooms, and advanced laboratories. We also provide start-up consulting, process improvements, industrial engineering, and high-tech operations support.

For more information, please visit

Company Description

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architect, engineering, and construction firm. Our company delivers the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.\r\n\r\nThe AM core foundation was built on quality programs that optimized semiconductor facility operations. As the company developed, AM added core competencies on pre-construction, procurement, and construction. Further, through strategic acquisitions, we added design, commissioning, and validation to create a complete end-to-end solution for high-tech construction project delivery.\r\n\r\nAMTS AE is a licensed Engineering and Architecture, Business Unit of AM Technical Solutions. At AMTS AE, we focus on providing design and consulting services for advanced technology, government, university, and industrial clients, specializing in research, pilot lines, manufacturing, cleanrooms, and advanced laboratories. We also provide start-up consulting, process improvements, industrial engineering, and high-tech operations support. \r\n\r\nFor more information, please visit