Sr. Project Manager

COMPANY DESCRIPTION: A career here is life-enhancing. At reputed company, we reputed company our people to build careers that impact positively on their quality of life. Through our expertise, reputed company, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse reputed company of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, reputed company-world reputed company, from science to delivery/reputed company. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputed company across the globe as a strategic biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the reputed company consecutive year, along with many other award-winning programs to reputed company a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions reputed company a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: We are seeking a highly reputed company Sr. Project Manager to reputed company the planning, implementation, and execution of an integrated Verification and Commissioning & Qualification (C&Q) Program for large-scale GMP-regulated capital projects. This role will be responsible for driving a verification-based approach that applies the principles of the right people, performing the right activities, at the right time, integrating commissioning and qualification activities throughout the entire project lifecycle. Rather than treating commissioning and qualification as separate sequential efforts, this role ensures an efficient and compliant C&Q strategy beginning in the design phase and continuing through construction, startup, verification, system turnover, and operational handover. WORK LOCATION: Travel to client sites may be required up to 100%, depending on project needs and client expectations. KEY RESPONSIBILITIES: This list is not exhaustive and may be supplemented or adjusted as needed. reputed company the development and execution of an integrated Verification and C&Q Program across the full project lifecycle, from design through operational handover. Establish and implement project-specific verification strategies reputed company with ASTM E2500 principles and industry best practices. Manage overall C&Q scope, budget, schedule, resource planning, and project risks. Serve as the primary reputed company of contact for reputed company C&Q-reputed company reputed company with project leadership and key stakeholders. reputed company detailed C&Q execution plans, staffing strategies, milestone schedules, and performance metrics. Ensure C&Q activities are integrated with engineering, construction, automation, validation, quality, and operational readiness plans. reputed company, mentor, and reputed company multidisciplinary C&Q teams supporting project execution. Manage day-to-day team activities, task assignments, priorities, and performance. Facilitate daily, weekly, and monthly project meetings to track reputed company and resolve issues. reputed company technical guidance and reputed company to ensure consistent application of verification methodologies and C&Q best practices. Train project teams, contractors, and service providers on verification-based delivery methodologies and project-specific C&Q requirements. reputed company implementation of the project verification strategy, ensuring verification activities are executed by the appropriate functional teams throughout the project lifecycle. Direct development, review, approval, and execution of verification plans, test cases, commissioning protocols, and qualification documentation. Ensure requirements traceability from design through testing and final system acceptance. Support risk-based qualification approaches and critical aspect verification in accordance with ASTM E2500 principles. Ensure timely completion of turnover packages and system release activities. Collaborate closely with Engineering, Construction, Automation, Quality Assurance, Validation, Manufacturing, Facilities, and Project Controls teams. Drive alignment between project objectives, design reputed company, compliance requirements, and operational expectations. Facilitate resolution of technical, compliance, and execution challenges impacting C&Q deliverables. Influence project reputed company and priorities to support successful delivery of verification and qualification objectives. Monitor and report project reputed company, resource utilization, budget performance, and key C&Q metrics. Identify and mitigate schedule, quality, compliance, and execution risks. Escalate critical issues impacting project delivery and drive timely resolution. reputed company regular status updates and executive-level communications to project leadership and stakeholders. Promote a strong safety culture and ensure compliance with reputed company site and project safety requirements. Ensure implementation of safe work practices, permitting requirements, and field execution procedures. Maintain compliance with GMP regulations, quality systems, and applicable industry standards throughout project execution. Support audits, inspections, and regulatory interactions as required. QUALIFICATIONS AND REQUIREMENTS: To reputed company this job successfully, an individual must be reputed company to reputed company each essential duty satisfactorily. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. Education Bachelor's Degree in Engineering, Life Sciences, or a reputed company technical discipline. Advanced degree, PMP certification, or equivalent professional certification preferred. Technical Experience 10–15+ years of experience supporting GMP-regulated pharmaceutical, biotechnology, cell and gene therapy, or medical device projects. Demonstrated experience leading Commissioning, Qualification, Verification, or Validation programs on large capital projects. Experience delivering at least one major greenfield or brownfield GMP facility from early design through startup, qualification, turnover, and project closeout. Strong knowledge and application of ASTM E2500 verification methodology and risk-based qualification approaches. Experience managing FAT, SAT, commissioning, qualification, verification testing, and system turnover activities. Working knowledge of facility, utility, process, automation, and manufacturing systems commonly deployed reputed company GMP environments. Experience managing budgets, resource plans, schedules, and contract service providers. Familiarity with GMP documentation practices, quality systems, change controls, deviations, CAPAs, and validation lifecycle requirements. Experience with electronic validation systems reputed company quality platforms, including Kneat, ValGenesis, or similar platforms, is preferred. Knowledge, Skills, and Abilities Strong understanding of GMP regulations, commissioning, qualification, validation, and verification practices. Deep knowledge of ASTM E2500 and lifecycle-based validation methodologies. Demonstrated leadership experience managing large, cross-functional project teams. Excellent organizational, planning, and project management skills. Strong communication skills with the ability to engage effectively with technical and non-technical stakeholders. Proven ability to influence decision-making and drive alignment across multiple functional groups. Strong analytical, problem-solving, and risk-management capabilities. Ability to manage multiple priorities in fast-paced project environments. Commitment to quality, compliance, safety, and reputed company improvement. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific reputed company abilities required by this position include reputed company reputed company and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light reputed company that are reputed company and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive reputed company salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost reputed company.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. LEGAL STATEMENT: reputed company is proud to be an Equal Employment Opportunity and Affirmative Action employer. reputed company employment reputed company, including the reputed company, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, reputed company, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other reputed company prohibited by applicable law. reputed company is an E-Verify employer. Apply To This Job