Investigator jobs at Takeda Pharmaceuticals U.S.A., Inc.

Job Title: Head of Global Investigative Toxicology About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. In the pharmaceutical industry, one of the major challenges in the discovery of innovative medicines is to ensure they are safe enough to serve patients - that is our mission. Drug safety is assessed throughout the R&D value chain, but it is during early drug discovery when we can actively design safety attributes into future candidate drug. We are supporting Drug Hunting partners in identification and optimization of new biological and synthetic molecule series applying cutting edge technologies pushing to the boundaries of predictive safety science with our mission in mind. We are also committed to the application of the 3Rs principles and to the implementation of New Alternative Methodologies (NAMs) in preclinical safety assessment. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: For our global investigative toxicology efforts we are looking for a strong Leader with focus on Investigative Toxicology. Activities include, but are not limited to: Leading our global investigative toxicology efforts with operations in Boston, Paris and Montpellier and with Senior Scientific Advisors serving as global safety experts in various toxicology disciplines based in multiple countries (France, US and Germany); develop/evolve strategy, ensure alignment and rationalization of activities across sites; ensure reaching out to internal and external ecosystem to develop/maintain networks and ensure access to appropriate methodologies/vendors; reach to other functions in R&D (Translational Medicine Unit, Research and Development) to share technologies / use synergies as applicable. Advice Preclinical Safety Project teams reps on building investigative toxicology strategy / review given strategies to progress projects successful overcoming challenges or rationale termination. Reporting to global Head PCS and Member of the global Leadership Team. Manage Senior Scientific Advisors globally. Strongly interact with Heads of Research Projects and Development projects Develop together innovative solutions and research proposals to pursue cutting edge science and technologies in order to optimize and influence translational safety assessment of novel drug targets. Facilitate and promote the use of new alternative methods (NAMs) in preclinical safety regulatory and non-regulatory testing. Serve globally as internal expert for discovery and development projects and design project-specific strategies to predict, assess and mitigate target- and modality-related safety risks and execute through internal and external experimental capabilities. Engage with experts across the organization to ensure that teams are able to make the right decisions regarding the translational safety risks associated with the project. Continuously interact with multiple R&D functions (TMU departments, Research and Development TAs, Research Platforms, etc ..) to identify opportunities to collaborate and utilize technologies across R&D more efficiently. Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities and contribute to Sanofi Outreach activities. Ensure high scientific standards / adhering to requested timelines in all aspects of the position. Supervision / Development of laboratory staff and global experts. About You Basic Qualifications: PhD or DVM and post-doctoral experience in toxicology, biochemistry, pharmacology, cell biology or systems biology. In addition, the candidate should have knowledge in biochemistry, toxicology, pharmacology, biology, physiology, and pathology. Solid understanding of the drug discovery and development process based on more than 20 years of experience in pharmaceutical industry in nonclinical drug safety and investigative toxicology. Demonstrated knowledge and experience investigating molecular mechanisms of drug action is critical. Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding. Knowledgeable about regulatory nonclinical testing requirements for pharmaceutical development of biologics and small molecules. Strong leadership competencies (as direct manager and transversal leader in a global and complex environment) and demonstrated experience. Preferred Qualifications: Highly motivated, creative, innovative, reliable scientist, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion. A social personality that contributes to an open, positive, collaborative working climate. Strong communication, presentation and influencing skills across levels/disciplines. DABT certification and experience as GLP Study Director is preferred, but not required. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Hybrid #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $228,750.00 - $381,250.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Contracting deliverables Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials Work with partners to develop and oversee the global site budget process Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline Collaboration Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives Compliance with Parexel standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Balance of general business, compliance, finance, legal, and drug development experience Precise communications and presentation skills Ability to plan, identify and mitigate risks to site contacting timelines Ability to lead by influence rather than positional power to accomplish critical deliverables Success in working in a highly matrix based organization Fluency in written and spoken English is required Knowledge and Experience: Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities Knowledge of the principles, concepts and theories in applicable business discipline Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred Education: Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Job Purpose: Conduct clinical studies according to study protocols, review safety data and monitor the safety of study participants enrolled into clinical trial protocols under the supervision of the Principal Investigator. Essential Functions * Maintain timely compliance with Celerion's SOPs, required study documents, and other study- specific mandatory trainings * Assist with training of new staff upon achieving personal proficiency in required skills and tasks. * Create a friendly and welcoming environment to study participants * Produce accurate and timely study data while ensuring participant safety * Participate in the ICF process by answering any volunteer questions about the study, in collaboration with the investigator as needed. * Conduct screening physical examinations * Review subject screening data, including subject medical histories, ECGs, laboratory studies, and any other ancillary tests as outlined by the study protocol. * Make preliminary eligibility decisions based on protocol inclusion and exclusion criteria. * Counsel participants regarding abnormal tests and make referrals in collaboration with the investigator as necessary * Attend Sponsor SIVs * Assist in the logistical setup of new studies by collaborating with the nursing department and working with study management to ensure the successful execution of all medical aspects of the protocol * Provide training to clinic associates as needed * Resolve queries During study * Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner * Conduct physical examinations * Perform minor procedures as outlined by the protocol following completion of required training * Engage with client in-person (on-site) or via written, electronic or telephone correspondence to address any medical-related issues * Ensure safety of study participants by reviewing and managing adverse events and serious adverse events under the supervision of the PI. Perform assessments and administer necessary treatment when required * Assist in referring participants to specialists as necessary * Review of outside medical records if requested by the investigator * Review of SUSAR reports if requested by the investigator * Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner * Conduct physical examinations * Resolve queries * A flexible schedule that could include Friday - Monday (start times may vary between 7am and 8am) for a minimum 10 hours a week Knowledge/Skills/Education/Licenses * Excellent oral and written communication skills * Proven organizational skills, ability to multi-task and manage multiple priorities * Demonstrates attention to detail * Strong customer service and interpersonal skills * Team player with the ability to work collaboratively * Willingness and ability to work flexible hours including weekends and holidays to ensure clinic coverage * Nurse Practitioner, Physician Assistant, or MD/DO * Eligible to obtain DEA certificate upon hire. * Training in Basic Life Support and Advance Cardiac Life Support, or willing to obtain upon hire * Board certified or board eligible in a primary care specialty, i.e. family practice, internal medicine, E.R. medicine or as a PA-C or NP, or MD/DO * 1 year medical experience and / or clinical research experience * Spanish language skills a plus Celerion Values: Integrity Trust Teamwork Respect Are you ready to join our team? Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

**Job Title:** Head of Global Investigative Toxicology **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. In the pharmaceutical industry, one of the major challenges in the discovery of innovative medicines is to ensure they are safe enough to serve patients - that is our mission. Drug safety is assessed throughout the R&D value chain, but it is during early drug discovery when we can actively design safety attributes into future candidate drug. We are supporting Drug Hunting partners in identification and optimization of new biological and synthetic molecule series applying cutting edge technologies pushing to the boundaries of predictive safety science with our mission in mind. We are also committed to the application of the 3Rs principles and to the implementation of New Alternative Methodologies (NAMs) in preclinical safety assessment. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** For our global investigative toxicology efforts we are looking for a strong Leader with focus on Investigative Toxicology. Activities include, but are not limited to: + Leading our global investigative toxicology efforts with operations in Boston, Paris and Montpellier and with Senior Scientific Advisors serving as global safety experts in various toxicology disciplines based in multiple countries (France, US and Germany); develop/evolve strategy, ensure alignment and rationalization of activities across sites; ensure reaching out to internal and external ecosystem to develop/maintain networks and ensure access to appropriate methodologies/vendors; reach to other functions in R&D (Translational Medicine Unit, Research and Development) to share technologies / use synergies as applicable. Advice Preclinical Safety Project teams reps on building investigative toxicology strategy / review given strategies to progress projects successful overcoming challenges or rationale termination. + Reporting to global Head PCS and Member of the global Leadership Team. + Manage Senior Scientific Advisors globally. + Strongly interact with Heads of Research Projects and Development projects + Develop together innovative solutions and research proposals to pursue cutting edge science and technologies in order to optimize and influence translational safety assessment of novel drug targets. + Facilitate and promote the use of new alternative methods (NAMs) in preclinical safety regulatory and non-regulatory testing. + Serve globally as internal expert for discovery and development projects and design project-specific strategies to predict, assess and mitigate target- and modality-related safety risks and execute through internal and external experimental capabilities. + Engage with experts across the organization to ensure that teams are able to make the right decisions regarding the translational safety risks associated with the project. + Continuously interact with multiple R&D functions (TMU departments, Research and Development TAs, Research Platforms, etc ..) to identify opportunities to collaborate and utilize technologies across R&D more efficiently. + Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities and contribute to Sanofi Outreach activities. + Ensure high scientific standards / adhering to requested timelines in all aspects of the position. + Supervision / Development of laboratory staff and global experts. **About You** **Basic Qualifications:** + PhD or DVM and post-doctoral experience in toxicology, biochemistry, pharmacology, cell biology or systems biology. In addition, the candidate should have knowledge in biochemistry, toxicology, pharmacology, biology, physiology, and pathology. + Solid understanding of the drug discovery and development process based on more than 20 years of experience in pharmaceutical industry in nonclinical drug safety and investigative toxicology. + Demonstrated knowledge and experience investigating molecular mechanisms of drug action is critical. + Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding. + Knowledgeable about regulatory nonclinical testing requirements for pharmaceutical development of biologics and small molecules. + Strong leadership competencies (as direct manager and transversal leader in a global and complex environment) and demonstrated experience. **Preferred Qualifications:** + Highly motivated, creative, innovative, reliable scientist, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion. + A social personality that contributes to an open, positive, collaborative working climate. + Strong communication, presentation and influencing skills across levels/disciplines. + DABT certification and experience as GLP Study Director is preferred, but not required. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SA \#LI-SA \#LI-Hybrid \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $228,750.00 - $381,250.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Apply Description Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company's Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness. Essential Duties and Responsibilities: • Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA's) at Nephron Pharmaceuticals Corporation. • Responsible for assisting with tracking and trending data related to investigations. • Assists in developing and implementing project plans, processes, and systems to ensure timely project completion. • Assists with additional work duties or responsibilities as evident or required. • Performs other duties as assigned or apparent. Supplemental Functions: Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc. Maintains investigation files. Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records. Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes. Track and report investigation trends. Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs). Assist with the design and development of organizational training programs, tools, and processes to build quality. Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs). Reports any quality related issues to Director of Quality Assurance Investigations. Assist in other activities (as needed) for Quality Assurance management. Job Specifications and Qualifications: Knowledge & Skills: • Written and Oral communication skills. • Team Player, must be able to interact within the company with all departments. • Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred. • Experience in Root Cause Analysis and technical writing skills required. • Specific expertise, skills and knowledge within Quality Assurance gained through education and experience. • A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. • The ability to take strategic objectives and accept accountability to drive results through effective actions. • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. • The ability to take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity. • The ability to manage a multitude of resources and to be accurate and current with data and information. • Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing. • Incumbents required wearing specified protective equipment as necessary. • Salary range: Based on experience. • Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands. Education/Experience: • Bachelor's degree with 3-5 years of pharmaceutical experience in Quality Systems preferred. • 1-3 years of experience with MS Word, Excel, and PowerPoint preferred. • 1-2 years project management and coordination experience preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company's Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness. Essential Duties and Responsibilities: * Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA's) at Nephron Pharmaceuticals Corporation. * Responsible for assisting with tracking and trending data related to investigations. * Assists in developing and implementing project plans, processes, and systems to ensure timely project completion. * Assists with additional work duties or responsibilities as evident or required. * Performs other duties as assigned or apparent. Supplemental Functions: * Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc. * Maintains investigation files. * Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records. * Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes. * Track and report investigation trends. * Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs). * Assist with the design and development of organizational training programs, tools, and processes to build quality. * Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. * Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs). * Reports any quality related issues to Director of Quality Assurance Investigations. * Assist in other activities (as needed) for Quality Assurance management. Job Specifications and Qualifications: Knowledge & Skills: * Written and Oral communication skills. * Team Player, must be able to interact within the company with all departments. * Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred. * Experience in Root Cause Analysis and technical writing skills required. * Specific expertise, skills and knowledge within Quality Assurance gained through education and experience. * A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. * The ability to take strategic objectives and accept accountability to drive results through effective actions. * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. * The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. * The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. • The ability to take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity. * The ability to manage a multitude of resources and to be accurate and current with data and information. * Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing. * Incumbents required wearing specified protective equipment as necessary. • Salary range: Based on experience. * Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands. Education/Experience: * Bachelor's degree with 3-5 years of pharmaceutical experience in Quality Systems preferred. * 1-3 years of experience with MS Word, Excel, and PowerPoint preferred. * 1-2 years project management and coordination experience preferred. Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace. Requirements