FDA Jobs in Philadephia, PA

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FDA Validation and IT Quality Director

RSM US LLP

Philadelphia, Pennsylvania, USA

Full-time

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there

Sr. Regulatory Operations Specialist

Zachary Piper Solutions, LLC

Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers. Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and pro

Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents.

ECQ Engineer

Zachary Piper Solutions, LLC

Hopewell Township, New Jersey, USA

Full-time

Piper Companies is currently seeking a ECQ Engineer for an opportunity in Titusville, New Jersey (NJ), to join a global pharmaceutical company. Responsibilities of the ECQ Engineer Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards Commission new laboratory equipment and decommissio

Director, Marketing Operations-Immunology

Johnson & Johnson

Horsham, Pennsylvania, USA

Full-time

Description Johnson & Johnson Innovative Medicine is recruiting for a Director, Marketing Operations to be located in Horsham, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full

HVAC PRODUCTION ENGINEER

Philly Shipyard Inc

Philadelphia, Pennsylvania, USA

Full-time

ESSENTIAL FUNCTIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Ensure that all PSI safety procedures, rules and regulations are followed and met. Perform field engineering activities for HVAC and refrigeration systems. Respond to issues by going onboard the vessel to investigate and document the issue. Interface with production superviso

MSAT Senior Process Engineer - LM DS

Johnson & Johnson

Malvern, Pennsylvania, USA

Full-time

Description Johnson & Johnson is hiring for an MSAT Senior Process Engineer - Large Molecule Drug Substance (LM DS)! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of h

Quality Control Manager

Ecolab

Norristown, Pennsylvania, USA

Full-time

As a Quality Control Manager with Purolite an Ecolab Company, you will establish quality control guidelines and testing procedures. You will ensure that raw material and finished product quality and reliability are in compliance with engineering and product specifications. Will review quality control practices and procedures to ensure that quality standards are upheld. What You Will Do: Responsible for overall management strategy for QC staff. Define priorities for the QC Analytical department

Associate Director, Clinical Pharmacology and Pharmacometrics (CPP)

Johnson & Johnson

Spring House, Pennsylvania, USA

Full-time

Description Johnson & Johnson is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) located in Spring House, PA or Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely posi

Associate Director, Field Access & Affordability Solutions-Oncology (Horsham, PA/Titusville, NJ)

Johnson & Johnson

Horsham, Pennsylvania, USA

Full-time

Description Associate Director, Field Access & Affordability Solutions Oncology About Us At Johnson & Johnson Innovative Medicine (JJIM), what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Job Description Johnson & Johnson Innovative Medicine's Patient Engagement and Customer Solutions (PECS) team is recru

Analytical Scientist - Automation

Thermo Fisher Scientific

Collegeville, Pennsylvania, USA

Full-time

Job Description Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to

Senior Engineering Manager

Apex Systems

Fort Washington, Pennsylvania, USA

Full-time

Job#: 2030853 Job Description: Apex Systems is partnering with our Manufacturing client and we are looking for a Sr. Engineering Manager. This is a Hybrid opportunity with the location in Lititz, PA. For immediate consideration, please send resumes to Sr. Engineering Manager The Senior Manager, Engineering and Automation provides technical leadership for the specification, development, implementation, and assurance of a qualified state for manufacturing equipment in the respective site. The

Solutions Architect--SAP EWM

ZealHire.com

Exton, Pennsylvania, USA

Contract, Third Party

USC need LinkedIn relocation or local candidates are needed Sr. Solutions Architect, SAP EWM to join one of our growing Medical Device clients in Exton, PA. The Sr. Solutions Architect, SAP EWM is accountable for collaborating with the IT SAP MM and the l IT, SAP SD in various locations to define, deliver and support IT enabled business solutions for the Operations, Supply Chain and Shipping functions. This role will also help determine business needs and design & deliver technical solutions

Healthcare Consultant - Life science (Quality Management System)

ADDSOURCE

Remote or Chicago, Illinois, USA

Third Party

Healthcare Consultant - Life science (Quality Management System) Onsite - Chicago, IL (3-4 days per week) Experience - 14-20 years Must have: Life Sciences consulting experience, Quality (QMS), SDLC & Regulatory (e.g conducting "As-Is" Assessments, "To Be" State definition and Pilot execution), GAMP Job Description 1. Experience in Life Sciences consulting projects related to Quality (QMS), SDLC & Regulatory (e.g conducting "As-Is" Assessments, "To Be" State definition and Pilot execution)

Web Application Developer

ClearBridge Technology Group

Remote

Contract

Our client, a leading Government Systems Integrator, is in need of a Web Application Developer for an initial 6 month remote contract. The Web Application Developer will be working within our customers Innovation Lab team which is responsible for developing POCs and use cases for new and existing customers. The Web Application Developer will provide end to end web development and will be primarily responsible for developing HCD (Human Centered Design) centric UIs and REST API development in an e

Senior Manager, Clinical Data and Reporting Standards (Remote)

Abbvie

Remote or Madison, New Jersey, USA

Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram,

AWS Developer

ClearBridge Technology Group

Remote

Contract

Our client, a leading Government Systems Integrator, is in need of an AWS Developer for an initial 6 month remote contract. The AWS Developer will be working within our customers Innovation Lab team which is responsible for developing POCs and use cases for new and existing customers. The AWS Developer will be primarily responsible for writing backend code using AWS services as well as making recommendations to customers on AWS application related tools and services. Required Skills: 5 - 7 year

Senior Director, Microbiologist-Sterilization (remote option)

Medtronic

Remote or Minneapolis, Minnesota, USA

Full-time

Careers that Change Lives A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, retore health, and extend life for millions of people worldwide. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Senior Director, Sterility Assurance will be responsible for all strategy, safety, quality, compliance, and execution of critical

Senior Medical Safety Specialist, Cardiac Ablation Solutions - Remote

Medtronic

Remote or Mounds View, Minnesota, USA

Full-time

Careers that Change Lives A career at Medtronic is like no other. We're purposeful. We're committed. We're driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide. We believe career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. We offer award-winning programs to accelerate your development and growth, and our size, scope, and market leadership help you explore career opportunitie

Senior Manager, Clinical Data and Reporting Standards (Remote)

Abbvie

Remote or San Francisco, California, USA

Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram,