Senior Project Manager, CQV

CRB; Dallas (TX); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a dynamic Sr. Project Manager for CQV to lead cGMP initiatives in the Life Sciences sector. This role emphasizes risk mitigation and compliance, ensuring that projects are delivered Right-the-First-Time. The ideal candidate will possess exceptional organizational and communication skills, fostering strong relationships with clients and internal teams. Embrace the opportunity to contribute to innovative solutions that address critical global health challenges while enjoying the flexibility of hybrid or remote work options. Join a forward-thinking firm that values employee experience and social responsibility.

Qualifications

• 8+ years of experience in CQV and compliance within Life Sciences.
• Bachelor’s Degree in relevant field or equivalent experience.
• Knowledge of US FDA regulations and ISPE guidelines.

Responsibilities

• Develop and formalize an ETOP package for clients.
• Write, review, and approve CQV documents per 21 CFR standards.
• Mentor commissioning and validation staff and project leaders.

Skills

cGMP compliance

Project Management

Communication Skills

Leadership

Risk Assessment

Education

Bachelor’s Degree in Architecture

Bachelor’s Degree in Engineering

Bachelor’s Degree in Construction Management

Tools

Validation Protocols

SOPs

Risk and Impact Assessments

Job description

Company Description

CRB's over 1,100 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.

As an AEC Firm, we proudly specialize in industries that inherently carry important social responsibility. We recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.

Job Description

CRB is seeking an energetic, self-motivated Sr. Project Manager for CQV. The role involves providing cGMP leadership and guidance for the integration and delivery of CQV services to our Life Sciences clients, ensuring solutions that are Right-the-First-Time (RFT), risk-mitigated, and compliant with timelines. The candidate should possess excellent organization, communication, and leadership skills, with the ability to build strong relationships with clients and internal teams. Professional representation of CRB, contribution to business development, and strategic impact awareness are essential.

This position offers hybrid or remote work options with travel requirements.

Responsibilities

1. Develop and formalize an ETOP package adaptable to various client approaches.
2. Support cGMP compliance-based services with Trade Partners and Clients as per the Project Scope.
3. Write, review, and approve CQV documents following 21 CFR standards, such as SOPs, Impact and Risk Assessments, Specifications, FATs, SATs, IOQ/PQs, Validation Protocols, and Test Plans.
4. Support onsite and offsite activities, including FATs, SATs, executions, and system walkdowns.
5. Prepare and review reports from Trade Partners on CQV, CV, CSV, and automation activities.
6. Review and approve URS, FRS, DDS, change controls, and FMEA documents.
7. Provide troubleshooting support during execution activities.
8. Train Client staff to enhance startup efficiency.
9. Collaborate with Market Team Leaders to ensure RFT delivery.
10. Plan and execute Smoke/Airflow Visualization Studies for various spaces.
11. Represent activities in discussions with Clients and regulatory agencies as a subject matter expert.
12. Implement and oversee system reviews and requalification activities.
13. Assess impacts of new or changed systems using a risk-based approach.
14. Mentor and guide commissioning and validation staff and project leaders.
15. Travel as needed and perform additional duties as assigned.

Qualifications

• Bachelor’s Degree in Architecture, Engineering, Construction Management, or related field, or equivalent experience.
• 8+ years of experience in CQV and compliance within Life Sciences or regulated industries, with knowledge of US and global regulations, cGMP, and SUPAC standards.
• Effective leadership and collaboration skills.
• Experience managing CQV deliverables across multiple projects.
• Excellent organizational, communication, and interpersonal skills.
• Commitment to technical excellence and client/employee experience.
• Knowledge of US FDA regulations, ISPE guidelines, and validation tools.

Additional Information

All information will be kept confidential per EEO guidelines. CRB is committed to diversity and equal opportunity employment. Employment is contingent on background screening. We do not accept unsolicited resumes from search firms or agencies. CRB offers comprehensive benefits. For accommodations during the application process, contact us.