Project Quality Manager-Pharmaceuticals

Requisition ID:295738

• Relocation Authorized:National - Family
• Telework Type:Full-Time Office/Project
• Work Location: Houston, TX

Extraordinary teams building inspiring projects:

Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place.

Differentiated by the quality of our people and our relentless drive to deliver the most successful outcomes, we align our capabilities to our customers' objectives to create a lasting positive impact. We serve the Infrastructure; Nuclear, Security & Environmental; Energy; Mining & Metals, and the Manufacturing and Technology markets. Our services span from initial planning and investment, through start-up and operations.

Core to Bechtel is our Vision, Values and Commitments. They are what we believe, what customers can expect, and how we deliver. Learn more about our extraordinary teams building inspiring projects in our Impact Report.

Project Overview:

Bechtel's Manufacturing & Technology (M&T) Business Unit is designing and building an Active Pharmaceutical Ingredient (API) Manufacturing Facility located at Generation Park in Houston, TX. M&T is an exciting and growing business unit that serves customers in the semiconductor, datacenter, life sciences, and electric vehicle markets. M&T strives to exceed our customer objectives through utilizing our agility, innovative technologies, and world class talent. M&T solves the industry's toughest challenges, building both our company and the world for the future. Headquartered in Reston, Virginia, the M&T global business unit also includes colleagues working in Arizona, Ohio, Texas, India, and additional project locations around the world.

Job Summary:

In this role located at the project job site, you will support the Project Quality Manager in leading project Quality teams to align the Quality culture, procedures, and programs with a business strategy to improve compliance, and project Quality performance. Manages the project Quality program for the project, together with oversight of both the direct hire scope, and the subcontracted scope. Scope of Quality program covers all project functions, including project management, engineering, procurement, construction, commissioning & startup, and project controls. Support the project Quality program relationship and communication with the customer representative responsible for project Quality. Advise the Project Quality Manager on status of project Quality culture, training, compliance, risk mitigation plans, and continuous improvement progress. Your leadership will elevate and maintain organizational Quality competencies, drive continuous improvement, and improve Quality performance. #LI-SM2

Major Responsibilities:

• Ensures compliance with project Quality procedures, contract requirements, design documents, codes, standards, and core programs
• Support the management and supervision of the overall project Quality team
• Interfaces and coordinates with the project functional managers and customer Quality team
• Supports the leading of project Quality execution planning and continuous improvement of procedures and core programs to improve Quality performance
• Builds and drives competency/training program to drive the Quality culture and processes across the project
• Implements guidance requirements for project Quality planning on project
• Supports the project level Quality Management System certification, and supports the project during audits conducted by client, GBU, Corporate, and other third parties, including regulatory agencies
• Supports the management of on project Quality auditing and assessments to verify the effectiveness of the Quality Management System (QMS) and Project Quality Plan (PQP) within the Project Execution Plan (PEP)
• Implements the PQP included in the PEP, including project completion documentation from start to finish of project
• Implements the Quality staff training plan during execution of the project
• Implements requirement for and preparation of project Quality performance metrics, dashboards, action plans, continuous improvement, and reports, including weekly and monthly reports
• Ensures compliance with project Quality requirements, QMS, PQP, including direct hire, subcontractor and vendor scopes of work
• Attend meetings representing the project Quality function, including project meetings, when invited to customer meetings, and when invited to M&T GBU meetings by the Manager of Quality

Education and Experience Requirements:

• Requires bachelor's degree (or international equivalent) in a scientific, engineering, or related discipline, 8+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices), and 12 -14years of overall relevant work experience.
• Demonstrated experience supporting site startups, major expansions, or large capital projects from a quality perspective.

Required Knowledge and Skills:

• College degree in engineering or technology, plus 10 years of experience in the implementation of quality related activities on major construction projects, including Pharma, data centers, Chip manufacturers, battery manufacturers, power plants, and refineries.
• Strong understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred 4 parenteral facilities).
• Strong working knowledge of GMP regulations, inspection readiness, validation, and quality systems.
• Experience working with regulatory submissions, approvals, and pre-approval inspections.Experience managing and supervising Quality teams and interfacing with project manager, functional managers, and customer Quality representatives.
• Experience associated with the development and coordination of quality activities for construction, manufacturing, system turnovers, commissioning / startup, and completions, including quality documentation turnover package.
• Knowledge of Engineering, Procurement, Construction project life cycle.
• Experience with fabrication of materials and equipment for large construction projects, including off-site manufacturing, and modularization.
• Prior experience developing and implementing quality programs, including Quality metrics, KPIs, and dashboards.
• Previous experience with auditing and surveillance programsWorking knowledge of incident investigations and root cause analysis

Total Rewards/Benefits:

For decades, Bechtel has worked to inspire the next generation of employees and beyond! Because our teams face some of the world's toughest challenges, we offer robust benefits to ensure our people thrive. Whether it is advancing careers, delivering programs to enhance our culture, or providing time to recharge, Bechtel has the benefits to build a legacy of sustainable growth. Learn more at Bechtel Total Rewards

Diverse teams build the extraordinary:

As a global company, Bechtel has long been home to a vibrant multitude of nationalities, cultures, ethnicities, and life experiences. This diversity has made us a more trusted partner, more effective problem solvers and innovators, and a more attractive destination for leading talent.

We are committed to being a company where every colleague feels that they belong-where colleagues feel part of "One Team," respected and rewarded for what they bring, supported in pursuing their goals, invested in our values and purpose, and treated equitably. Click here to learn more about the people who power our legacy.

Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age,national origin, disability, citizenship status (except as authorized by law),protected veteran status, genetic information, and any other characteristic protected by federal, state or local law. Applicants with a disability, who require a reasonable accommodation for any part of the application or hiring process, may e-mail their request to View email address on click.appcast.io