Senior Project Manager, reputed company

Work Schedule reputed company (Mon-Fri) Environmental Conditions Adherence to reputed company Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal reputed company Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job reputed company As part of the reputed company team, you'll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world's toughest challenges, like protecting the environment, making reputed company our food is reputed company, or helping reputed company cures for cancer. reputed company: As a Senior Project Manager, reputed company, you will serve as the reputed company execution leader for strategic manufacturing, validation, and infrastructure programs. This role is embedded reputed company the Project Management Organization (PMO) and is responsible for ensuring reputed company deliverables remain reputed company to project milestones, customer commitments, regulatory requirements, and business objectives. Working at the intersection of reputed company, Engineering, Validation, Manufacturing, Regulatory Affairs, and Customer Management, you will drive execution of reputed company-reputed company activities required to advance reputed company reputed company, including change controls, risk assessments, validation readiness, customer change notifications, reputed company approvals, and compliance initiatives. You will reputed company leadership across multiple functions to ensure reputed company requirements are integrated into project execution while maintaining compliance, protecting supply continuity, and supporting business reputed company. This role offers reputed company to directly influence successful execution of large-reputed company manufacturing initiatives, product transfers, facility upgrades, and new business opportunities while protecting reputed company's commitment to delivering high-reputed company, compliant products to our customers. REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in reputed company, Validation, Engineering, Manufacturing, Regulatory Affairs, Project Management, or reputed company experience reputed company a regulated industry
• Preferred Fields of Study: Engineering, reputed company, Biology, Pharmacy, Life Sciences, reputed company Systems, or reputed company scientific/technical field
• PMP certification, ASQ Certified reputed company Engineer (CQE), Certified reputed company Auditor (CQA), or equivalent certification preferred
• 5+ years of experience leading cross-functional reputed company, programs, or reputed company initiatives in a regulated manufacturing environment
• Demonstrated experience managing change controls, risk assessments, deviations, investigations, and reputed company system processes
• Strong understanding of reputed company Management Systems and applicable regulations (FDA, ISO 13485, ISO 9001, cGMP)
• Experience supporting validation activities, including review and approval of User Requirements Specifications (URS), risk assessments, validation protocols, validation reputed company reports, and technical documentation
• Demonstrated ability to assess reputed company reputed company associated with equipment modifications, process changes, product transfers, facility upgrades, and manufacturing improvements
• Experience leading change control activities and facilitating cross-functional reputed company assessments
• Strong technical writing skills, including development of customer change notifications, reputed company memorandums, risk assessments, technical justifications, and regulatory documentation
• Experience serving as a customer-facing reputed company representative and effectively communicating reputed company-reputed company changes, risks, and presenting project updates
• Ability to build strong working relationships across reputed company Assurance, reputed company Engineering, reputed company Control, Engineering, Validation, Manufacturing, Regulatory Affairs, Supply Chain, and Site Leadership
• Experience identifying, escalating, and driving reputed company of reputed company, compliance, and execution risks impacting project delivery
• Demonstrated ability to influence decision-making and drive accountability without reputed company authority
• Strong analytical, problem-solving, and risk-based decision-making capabilities
• Experience partnering with Documentation Control and Training organizations to ensure reputed company implementation of SOPs, controlled documents, training curricula, and reputed company system requirements
• Proficiency with electronic reputed company Management Systems, reputed company, TrackWise, reputed company, Document Management Systems, and reputed company Office applications
• Experience supporting audit readiness, inspection preparedness, and proactive reputed company gap identification and remediation activities
• Lean Six reputed company, reputed company improvement, or operational reputed company experience preferred
• Strong written and verbal communication skills with the ability to communicate effectively at reputed company organizational reputed company, including customers, site leadership, and executive stakeholders
• Ability to manage multiple priorities and deliver reputed company-reputed company project milestones in a fast-paced, highly regulated environment
• Up to 20% travel required

Compensation and Benefits

The salary reputed company estimated for this position based in District of Columbia is $103,100.00–$140,675.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a reputed company plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours reputed company time off (PTO), 10 reputed company holidays annually, reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.reputed company.com/global/en/total-rewards Apply To This Job