Talascend is seeking a professional, skilled individual for our Construction Quality Manager position located in Richmond, VA.
Functional job responsibilities will include but are not limited to:
Quality Leadership & Governance
Engineering & Design Quality Oversight
Construction Quality Oversight
Supplier & Equipment Quality Management
CQV & GMP Compliance
Audit & Compliance Management
Team Leadership
Required Education & Experience
Preferred Qualifications
Functional job responsibilities will include but are not limited to:
Quality Leadership & Governance
- Develop and implement the Project Quality Management Plan (QMP).
- Establish project-wide quality objectives, KPIs, quality reporting systems, and governance processes.
- Lead project quality reviews, audits, management assessments, and compliance evaluations.
- Provide independent assurance regarding effectiveness of contractor and project quality management systems.
- Guide project leadership on quality risks, compliance concerns, and required corrective actions.
- Promote a quality-focused culture emphasizing right-first-time execution and continuous improvement.
Engineering & Design Quality Oversight
- Oversee design quality review processes and contractor quality programs.
- Ensure management of design changes, deviations, and quality impacts.
- Confirm quality requirements are incorporated into all project execution procedures and standards.
Construction Quality Oversight
- Manage owner-side construction quality surveillance and inspection programs.
- Monitor contractor QA/QC performance across civil, structural, architectural, mechanical, electrical, instrumentation, automation, utilities, and process installation activities.
- Review and approve Inspection and Test Plans (ITPs), turnover strategies, punch list management processes, and inspection procedures.
- Ensure construction activities comply with approved specifications, codes, standards, and regulatory requirements.
- Lead quality investigations associated with nonconforming work.
Supplier & Equipment Quality Management
- Oversee supplier quality programs for major process equipment, utilities, automation systems, cleanroom systems, and critical GMP infrastructure.
- Support supplier qualification, audits, surveillance activities, and factory acceptance testing.
- Review supplier quality performance metrics and corrective action programs.
- Ensure documentation and quality records support qualification and validation activities.
CQV & GMP Compliance
- Coordinate closely with Commissioning, Qualification, Validation, and Compliance teams.
- Ensure construction and engineering activities support successful CQV execution.
- Verify quality documentation supports GMP regulatory inspections and licensure requirements.
- Support readiness for FDA, EMA, MHRA, and other applicable regulatory agency inspections.
- Ensure proper management of deviations, CAPAs, change controls, and quality records.
Audit & Compliance Management
- Develop and execute project quality audit programs.
- Lead internal quality audits and support external regulatory assessments.
- Track audit findings and corrective actions through closure.
- Monitor contractor compliance with contractual quality obligations.
- Maintain project quality dashboards and executive reporting.
Team Leadership
- Coordinate quality activities among EPCM firms, contractors, suppliers, and CQV partners.
- Foster collaboration across Quality, Construction, Engineering, Procurement, and Operations teams.
Required Education & Experience
- Bachelor's degree in Engineering, Construction Management, Quality Management, Life Sciences, or related technical discipline.
- Minimum 15 years of quality management experience supporting major capital projects.
- Minimum 10 years of experience within pharmaceutical, biotechnology, life sciences, sterile manufacturing, vaccine, biologics, API, or other GMP-regulated industries.
- Demonstrated experience supporting projects exceeding $500 million TIC.
- Experience managing quality programs during design, construction, CQV, startup, and handover phases.
- Extensive knowledge of GMP requirements and pharmaceutical facility delivery processes.
- Proven ability to lead multidisciplinary quality organizations and contractor teams.
Preferred Qualifications
- ASQ Certified Quality Manager (CMQ/OE), Certified Quality Engineer (CQE), or equivalent certification.
- Professional Engineer (PE), PMP, or comparable certification.
- Experience on greenfield pharmaceutical manufacturing projects.
- Experience supporting FDA, EMA, MHRA, or similar regulatory inspections.
- Experience with cleanrooms, sterile processing, biologics, cell and gene therapy, or advanced manufacturing facilities.
- Previous Owner's Representative, PMC, or EPCM oversight experience on mega-projects.
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.