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Senior Director, Laboratory Systems & Operations, PSG

Pharmaceutical Product Development (PPD)

Remote, North Carolina, United States of America

Job Description

Job Description :Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.Position SummaryAs a member of the Quality Leadership team, the Head of Laboratory Systems & Operations, Pharmaceutical Services Group (PSG), will develop and implement the overall QC laboratory strategy and roadmap to ensure compliance, technical and operational performance of our Quality Control & Analytical Development Laboratories. They will be responsible for the global laboratory strategy, policies, procedures, and processes to ensure reliable, efficient, and compliant testing. This role will lead transformation efforts to implement Lean Laboratories and standardize laboratory systems across all PSG sites. The position will work closely with all PSG laboratories worldwide to ensure alignment and execution.Key Responsibilities:• Responsible for strategic cGMP & scientific leadership for PSG Quality Control and analytical development laboratories.• Accountable for ongoing transformation efforts within QC to increase performance, efficiency, and profitability across all PSG sites through the implementation of appropriate strategies (e.g. Lean Labs) and our Practical Process Improvement (PPI) program to deliver improved performance and profitability• Collaborate with divisions to establish and implement strategies such as additional testing offerings, insource/outsource models, centralized testing etc.• Ensure our laboratories maintain an industry-leading scientific presence and cGMP complaint testing capabilities.• Foster the culture of proactive performance management and continuous improvement.• Lead a team and implement all aspects of Thermo Fisher people process.• Provide PSG standards for laboratory instrumentation, automation, and informatics solutions.• Build and maintain global QC policies, standards, and global SOPs.• Coordinates global technical responses to questions & issues raised by regulatory agencies and customers related to QC laboratory operations.• Represents the company as a subject matter authority as required.• Collaborates on projects at individual sites and the multi-site level to meet customer, business, and regulatory requirements.• Own the global QC community of practice.• Develop and report metrics and key performance indicators (KPIs) to monitor Quality Control laboratory compliance, scientific proficiency, and performance.• Monitor and analyze the QC laboratory program and drive improvements as required.• Supports company integration activities with regards to Quality Control Laboratories.• Stay current on industry and regulatory QC Laboratory trends, communicates and adapt the quality system and program as necessary. Participates in external influence strategy.Requirements:• Bachelor’s Degree in Chemistry, Life Sciences, Biochemistry, or related field of study. Advanced Degree (MS, PhD, Pharm D) preferred.• Minimum of 15 years’ experience with growing leadership responsibility in a GMP Quality Control laboratory and /or analytical development function within a pharmaceutical environment.• Commanding knowledge of QC laboratory operations, cGMPs and regulations.• In depth knowledge of laboratory instrumentation and analytical laboratory informatics.• Proven leadership capabilities working in a global multi- site environment and influencing without direct authority.• Excellent verbal & written communication skills required to communicate at all levels of the organization (front-line to Executive Committee) required.• Ability to closely partner with customers and clients (internal or external).• Requires 30-50% travel.Benefits:We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasonsto workwith us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement -working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.EEO/Reasonable Accommodation:Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Thermo Fisher Scientific is an EEO/Affirmative Action Employer anddoes not discriminate on the basis of race, color,religion,sex,sexualorientation, genderidentity, national origin, protected veteran status,disability or any otherlegally protected status

Job posted: 2024-04-30

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