Senior Project Manager, Quality

Emploi pas sur LinkedIn

🕒 il y a 4 jours

🏛️ District of Columbia – Distant

🏛️ District of Columbia – Remote

💵 $130 000 - $194 950 / an

⏰ Temps Plein

🟠 Senior

👷‍♀️ Chef de Projet

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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Serve as the quality execution leader for strategic manufacturing, validation, and infrastructure programs • Drive execution of quality-related activities required to advance complex projects, including change controls, risk assessments, validation readiness, customer change notifications, quality approvals, and compliance initiatives • Provide leadership across multiple functions to ensure quality requirements are integrated into project execution while maintaining compliance, protecting supply continuity, and supporting business growth • Directly influence successful execution of large-scale manufacturing initiatives, product transfers, facility upgrades, and new business opportunities while protecting Thermo Fisher Scientific's commitment to delivering high-quality, compliant products to our customers

🎯 Exigences

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in Quality, Validation, Engineering, Manufacturing, Regulatory Affairs, Project Management, or related experience within a regulated industry • Preferred Fields of Study: Engineering, Chemistry, Biology, Pharmacy, Life Sciences, Quality Systems, or related scientific/technical field • PMP certification, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred • 5+ years of experience leading cross-functional projects, programs, or quality initiatives in a regulated manufacturing environment • Demonstrated experience managing change controls, risk assessments, deviations, investigations, and quality system processes • Strong understanding of Quality 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 summary reports, and technical documentation • Demonstrated ability to assess quality 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, quality memorandums, risk assessments, technical justifications, and regulatory documentation • Experience serving as a customer-facing quality representative and effectively communicating quality-related changes, risks, and presenting project updates • Ability to build strong working relationships across Quality Assurance, Quality Engineering, Quality Control, Engineering, Validation, Manufacturing, Regulatory Affairs, Supply Chain, and Site Leadership • Experience identifying, escalating, and driving resolution of quality, compliance, and execution risks impacting project delivery • Demonstrated ability to influence decision-making and drive accountability without direct authority • Strong analytical, problem-solving, and risk-based decision-making capabilities • Experience partnering with Documentation Control and Training organizations to ensure timely implementation of SOPs, controlled documents, training curricula, and quality system requirements • Proficiency with electronic Quality Management Systems, MasterControl, TrackWise, SAP, Document Management Systems, and Microsoft Office applications • Experience supporting audit readiness, inspection preparedness, and proactive quality gap identification and remediation activities • Lean Six Sigma, continuous improvement, or operational excellence experience preferred • Strong written and verbal communication skills with the ability to communicate effectively at all organizational levels, including customers, site leadership, and executive stakeholders • Ability to manage multiple priorities and deliver quality-related project milestones in a fast-paced, highly regulated environment • Up to 20% travel required

🏖️ Avantages

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid 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 the opportunity to purchase company stock at a discount