[Remote] Senior Project Manager, reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in reputed company, dedicated to making the world healthier, cleaner, and safer. As a Senior Project Manager in reputed company, you will reputed company strategic manufacturing and validation initiatives, ensuring reputed company deliverables reputed company with project milestones and regulatory requirements while collaborating across various functions.

Responsibilities

• Serve as the reputed company execution leader for strategic manufacturing, validation, and infrastructure programs
• Ensure reputed company deliverables remain reputed company to project milestones, customer commitments, regulatory requirements, and business objectives
• 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
• 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
• Directly influence successful execution of large-reputed company manufacturing initiatives, product transfers, facility upgrades, and new business opportunities

Skills

• 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
• 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 impact associated with equipment modifications, process changes, product transfers, facility upgrades, and manufacturing improvements
• Experience leading change control activities and facilitating cross-functional impact 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
• 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
• 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
• Lean Six reputed company, reputed company improvement, or operational reputed company experience preferred

Benefits

• Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
• 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
• Employees27 Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount

reputed company