Job Title: Construction Quality Lead – Pharmaceutical Industry
Location: Wilson, NC
Job Type: Contract position
Reports to: Director of Quality Assurance / Construction Manager
Overview:
We are seeking an experienced and highly motivated Construction Quality Lead with over 15 years of experience in the pharmaceutical industry to oversee and ensure the highest standards of construction quality. The ideal candidate will be responsible for ensuring compliance with the construction quality plan, managing material and equipment verification processes, conducting inspections, and ensuring adherence to industry regulations and project specifications. The Construction Quality Lead will also oversee the documentation and reporting associated with quality management throughout the project lifecycle along with the EPCM of record.
Key Responsibilities:
1. Construction Quality Plan Development & Compliance:
o Prepare, implement, and monitor the construction quality plan to ensure that quality
requirements for all construction activities are met.
o Ensure that all construction activities comply with company, regulatory, and industry
standards, including GMP (Good Manufacturing Practices) and cGMP (current Good
Manufacturing Practices).
o Provide guidance and oversight to the project team to ensure alignment with quality
plan objectives and protocols.
2. Material and Equipment Verification:
o Oversee and manage the receipt and verification process for all construction materials,
equipment, and products used on the project as necessary.
o Ensure that all materials and equipment meet specified requirements, including
reviewing certificates of compliance, vendor data, and material certifications.
o Maintain records of receipt, verification, and acceptance of materials and equipment.
3. Quality Standards & Workmanship:
o Establish and enforce quality standards for workmanship on-site, ensuring construction
activities meet or exceed client and regulatory expectations.
o Provide technical guidance and training to construction teams to ensure consistent
application of quality standards.
o Conduct regular audits and inspections of construction work to monitor workmanship
quality and identify areas for improvement.
4. Pre-Construction Meetings & Inspections:
o Lead pre-construction meetings to discuss quality standards, procedures, and
expectations with contractors, subcontractors, and project teams.
o Ensure that quality control measures and inspection processes are clearly understood by
all stakeholders.
o Perform regular inspections of ongoing construction work to ensure compliance with the
quality plan and specifications.
5. Inspection and Test Reports:
o Conduct routine inspections of construction activities, systems, and installations to
ensure compliance with quality standards and regulatory requirements.
o Document findings in detailed inspection reports and test reports, ensuring accuracy,
completeness, and compliance with the project’s requirements.
o Coordinate and schedule any necessary re-inspections and corrective actions for non-
compliant work.
6. Follow-Up Inspections:
o Perform follow-up inspections to verify that corrective actions have been implemented
for any non-compliant or deficient work.
o Ensure that any rework or adjustments are properly documented and meet the
necessary quality standards.
o Provide feedback to project teams to promote continuous improvement in construction
quality.
7. Documentation & Record Keeping:
o Maintain accurate and up-to-date records of all inspections, tests, and quality control
activities throughout the project lifecycle.
o Ensure proper documentation of all compliance, verification, and inspection reports in
line with regulatory and company requirements.
o Prepare and submit regular quality reports to senior management and stakeholders,
highlighting key quality metrics, issues, and resolutions.
8. Collaboration & Communication:
o Work closely with construction managers, project engineers, subcontractors, and
suppliers to ensure a smooth and efficient workflow while maintaining quality standards.
o Act as the point of contact for all quality-related issues on the construction site, ensuring
effective communication across teams.
o Support project management teams with guidance on quality-related risks, corrective
actions, and improvement opportunities.
Required Skills & Qualifications:
• Education: Bachelor’s degree in Construction Management, Civil Engineering, Quality
Management, or a related field. Relevant certifications (e.g., ISO 9001, Six Sigma) are a plus.
• Experience:
o 15+ years of experience in construction quality management within the pharmaceutical
or life sciences industry.
o Proven track record of preparing and complying with quality plans for large-scale
construction projects in a regulated environment.
o Experience with construction material and equipment verification, inspections, and
conducting quality audits.
o Familiarity with GMP, cGMP, and other relevant pharmaceutical industry regulations.
o Strong knowledge of quality management systems, inspection techniques, and
construction standards.
o In-depth understanding of pharmaceutical construction requirements, including HVAC,
clean rooms, and controlled environments.o Excellent communication and leadership skills to collaborate with cross-functional teams
and ensure quality standards are met.
o Strong attention to detail, organizational skills, and the ability to manage multiple tasks
simultaneously.
o Proficiency with quality management software, document control systems, and MS
Office Suite.
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